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Medical Device Recall Listings - Sorted by Trade Name
(From July 2005 - September 2005)
- Trade Name
- 3M Microfoam Surgical Tape
- Recall Posting Date
- 2005-09-05
- Manufacturer
- 3M Health Care
- Recall Start Date
- 2005-08-08
- Recall Number
- 28764
- Hazard Classification
- Type III
- Model or Catalog #
- 1528-1, 1528-2, 1528-3, 1528-4
- Lot or Serial #
- 2010-06 (HE, HR, HS, HU, IM, IN)
- Reason for Recall
- The tape may not perform as intended in some situations as portions of the tape may not appear to have adhesive or the adhesive may separate from the foam backing.
- Trade Name
- A) Access Immunoassay Sys: Dil-AFP
B) Access Immunoassay Sys: Dil-AFP - Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-07-21
- Recall Number
- 28789
- Hazard Classification
- Type III
- Model or Catalog #
- A) 33211
B) 33210 - Lot or Serial #
- A) All lots.
B) All lots - Reason for Recall
- Potential splashing may cause erroneous results.
- Trade Name
- A) ACL Futur A/ACLl Advance
B) ACL Top - Recall Posting Date
- 2005-09-19
- Manufacturer
- Instrumentation Laboratory Co.
- Recall Start Date
- 2005-05-19
- Recall Number
- 28468
- Hazard Classification
- Type II
- Model or Catalog #
- A) 280000, 999001
B) N/A - Lot or Serial #
- A)Serial number starting with 05041164, Serial number with 0505354.
B) N/A - Reason for Recall
- Patient prothrombin time (PT) may report low for individuals on anticoagulent therapy.
- Trade Name
- A) Alto VR625 Cardioverter Defibrillator
B) Alto DR614 Cardioverter Defibrillator
C) Alto 2 DR624 Cardioverter Defibrillator - Recall Posting Date
- 2005-09-05
- Manufacturer
- ELA Medical, S.A.
- Recall Start Date
- 2005-07-20
- Recall Number
- 28746
- Hazard Classification
- Type I
- Model or Catalog #
- A) N/A
B) 614
C) N/A - Lot or Serial #
- A) 304XI002, 304XI108, 402XI001, 404XI049, 413XI027, 413XI035
B) 222XF028, 222XF035, 222XF085, 222XF079, 222XF033
C) 314XJ284, 238XJ029, 403XJ002, 403XJ092, 409XJ014, 409XJ036, 410XJ019, 410XJ024, 410XJ025, 410XJ031, 410XJ042 - Reason for Recall
- Premature battery depletion and
- Trade Name
- A) Arcadis Varic
B) Siremobil Compact - Recall Posting Date
- 2005-09-05
- Manufacturer
- Siemens Aktiengesellschaft
- Recall Start Date
- 2005-08-08
- Recall Number
- 28754
- Hazard Classification
- Type III
- Model or Catalog #
- A) 8080017
B) 3780629 - Lot or Serial #
- A) N/A
B) 10051, 10243, 10256, 1639 - Reason for Recall
- The screws fixing the laser diode out windows can become loosened.
- Trade Name
- A) Axiom Aristos FX
B) Axiom Aristos MX - Recall Posting Date
- 2005-07-11
- Manufacturer
- Siemens Aktiengesellschaft
- Recall Start Date
- 2005-06-14
- Recall Number
- 28493
- Hazard Classification
- Type III
- Model or Catalog #
- A) 7414803
B) 5895003 - Lot or Serial #
- A) 1298, 1120, 1129, 1131, 1292, 1288, 1086, 1236, 1006, 1243, 1018, 1311, 1315, 1326, 1340, 1354, 1153, 1443, 1337, 1173, 1190, 1244, 1072,
1273, 1175, 1124, 1134, 1272, 1333, 1145, 1386,1065, 1328, 1162, 1128, 1119, 1176.
B) N/A - Reason for Recall
- A system lock-up may occur when repeating patient registrations under a specific workflow.
- Trade Name
- A) Axiom Artis BA
B) Axiom Artis DFC
C) Axiom Artis FA ALPHA
D) Axiom Artis MP
E) Axiom Artis TA - Recall Posting Date
- 2005-08-22
- Manufacturer
- Siemens Aktiengesellschaft
- Recall Start Date
- 2005-07-26
- Recall Number
- 28718
- Hazard Classification
- Type III
- Model or Catalog #
- A) 5904656
B) 7412807, 7727717
C) 5904441
D) 5904466
E) 7007755 - Lot or Serial #
- A) N/A
B) 35195, 35261, 35219, 35298, 40033, 25006, 25076, 20070, 20215, 28064, 32070
C) N/A
D) N/A
E) N/A - Reason for Recall
- The live display of the Axiom Artis in the examination room may sporadically stop working.
- Trade Name
- A) AXSYM Total B-HCG Reagent
B) IMX Total B-HCG Reagent - Recall Posting Date
- 2005-08-08
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-04-05
- Recall Number
- 28629
- Hazard Classification
- Type III
- Model or Catalog #
- A) 1A06-22
B) 7A59-22 - Lot or Serial #
- A) 26148Q100, 26278Q100, 16381Q100
B) 25459Q100 - Reason for Recall
- Tests have shown that protein aggregates are present in the specimen diluent and causes calibration errors and a shift in control values and no valid patient results could be generated.
- Trade Name
- A) Brilliance CT 16 Slice
B) Brilliance CT 16 Power
C) Brilliance CT 40 Channel - Recall Posting Date
- 2005-08-08
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
- Recall Start Date
- 2005-07-18
- Recall Number
- 28640
- Hazard Classification
- Type II
- Model or Catalog #
- A) 453567078851
B) 453567005721
C) 455011004011 - Lot or Serial #
- A) 5074
B) 6110
C) 9081, 6072 - Reason for Recall
- Couch positions that are reported on the gantry control panel are correct during a CCT procedure, but the couch positions that are displayed on the monitor may be incorrect.
- Trade Name
- A) CA1500 Instrument
B) CA540 Instrument
C) CA560 Instrument - Recall Posting Date
- 2005-08-22
- Manufacturer
- Sysmex Corporation
- Recall Start Date
- 2005-07-21
- Recall Number
- 28685
- Hazard Classification
- Type II
- Model or Catalog #
- A) CA-1500WBCR
B) B4260-540
C) B4260-560 - Lot or Serial #
- A) A2399, A2483, A2400, A3358, A2401, A2727, A1888, A3295, A3276, A3632, A2620, A2739, A1825, A2270, A2753, A2522, A1556, A3905, A2480, A4001, A2636, A3546, A2320, A1465, A1151, A2646, A4047, A4050, A3548, A2713, A2269, A2271, A3634, A1646, A2182, A2170, A3521, A4028, A2171, A3284, A1105, A1581, A2427, A2257, A2632, A2621, A1644, A2296.
B) A3616, A2858, A3359, A2530, A2578, A2353, A2536, A3250, A1307, A2384, A3637, A1449, A2993, A2954, A3729, A2352, A3406, A3249, A2005, A2996, A2246, A2854, A2308, A3273, A3274, A3687, A3360, A2841, A1452, A3482, A2859, A3407, A3403, A2474, A2351, A2953, A1309, A2027, A2248, A3636, A2997, A3602, A3477, A3600, A3599, A3345, A2861, A2309, A2995, A2532, A1308, A2531, A3446. A3417, A3548, 2026, A2759, A2003, A1454, A3479, A3297, A3321, A3320, A2952, A3361, A3362, A3394, A3478, A3447, A2004B, A2994, A3404, A1456, A3409, A2862, A2863, A2857, A2860, A3452, A3319, A3344, A3401, A3483, A3450, A3475, A2490, A1450, A2395, A2840, A2955, A3405, A3296, A2951, A3311, A3318, A3448, A3662, A3772, A1457, A3476, A3667, A3783, A3927, A2337.
C) A1323, A1413, A1088, A1821, A1336, A1633, A1276, A1315, A1102. A1850, A1858, A1105, A1510, A1395, A1870, A1866, A1856, A1846, A1869, A1474, A1103, A1113, A1839, A1108, A1290, A1861, A1265, A1278, A1672, A1630, A1198, A1770. - Reason for Recall
- Manufacturer has found an issue when using the akima method of calculating the standard curve. A change to the standard curve method for this assay is needed.
- Trade Name
- A) Colleague 3 Volumetric Infusion Pump
B) Colleague Volumetric Infusion Pump - Recall Posting Date
- 2005-08-08
- Manufacturer
- Baxter Healthcare Corporation
- Recall Start Date
- 2005-07-21
- Recall Number
- 28660
- Hazard Classification
- Type I
- Model or Catalog #
- A) 2M8153, 2M8163, DNM8153
B) 2M8151, 2M8161, DNM8151 - Lot or Serial #
- A) All Serial Numbers / Tous les numéros de séries
B) All Serial Numbers / Tous les numéros de séries - Reason for Recall
- Design problem with the clocking circuit that can disrupt internal communications causing the pumps to shut down with certain error codes and disrupt critical medication infusions. Death has been involved.
- Trade Name
- A) Contak Renewal 2
B)Contak Renewal - Recall Posting Date
- 2005-07-25
- Manufacturer
- Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
- Recall Start Date
- 2005-06-21
- Recall Number
- 28519
- Hazard Classification
- Type II
- Model or Catalog #
- A) H135
B) H155 - Lot or Serial #
- A) N/A
B) N/A - Reason for Recall
- Deterioration in a wire insulator within the lead connector block, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.
- Trade Name
- A) Contak Renewal 4 AVT
B) Contak Renewal 4 AVT HE
C) Contak Renewal 4
D) Contak Renewal 4 HE - Recall Posting Date
- 2005-07-25
- Manufacturer
- Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
- Recall Start Date
- 2005-06-24
- Recall Number
- 28531
- Hazard Classification
- Type II
- Model or Catalog #
- A) M170, M175
B) M177, M179
C) H190, H195
D) H197, H199 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A - Reason for Recall
- Component failure may limit available tachyarrhythmia therapy. The magnetic switch might stick in the closed position.
- Trade Name
- A) Contak Renewal 4 AVT
B) Contak Renewal 4 AVT HE
C) Ventak Prizm AVT
D) Vitality AVT - Recall Posting Date
- 2005-07-25
- Manufacturer
- Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
- Recall Start Date
- 2005-06-21
- Recall Number
- 28528
- Hazard Classification
- Type II
- Model or Catalog #
- A) M170, M175
B) M177, M179
C) 1900
D) A135, A155 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A - Reason for Recall
- Random memory error causes functional "latching" that limits available therapy. Latching can only occur when storing tachy detection
- Trade Name
- A) Contak Renewal 4 AVT
B) Contak Renewal 4 AVT HE
C) Ventak Prizm AVT
D) Vitality AVT AICD - Recall Posting Date
- 2005-08-08
- Manufacturer
- Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
- Recall Start Date
- 2005-07-22
- Recall Number
- 28665
- Hazard Classification
- Type II
- Model or Catalog #
- A) M170, M175
B) M177
C) 1900
D) A155 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A - Reason for Recall
- One of the original recommendations to recall #28528 - programming atrial tachy episode data storage to 0% - can cause latching in a subset of AVT devices that have previously stored atrial episode data.
- Trade Name
- A) Contak TR CHFD
B) CPI Discovery DR Pacemaker
C) CPI Discovery SR Pacemaker
D) CPI Meridian DDD Pacemaker
E) CPI Meridian DR Pacemaker
F) CPI Meridian SR Pacemaker
G) CPI Meridian SSI Pacemaker
H) CPI Pulsar DDD, Model 970 Pacemaker
I) CPI Pulsar DDD, Model 972 Pacemaker
J) CPI Pulsar DR Pacemaker
K) CPI Pulsar Max DR Pacemaker
L) CPI Pulsar Max SR, Model 1170 Pacemaker
M) CPI Pulsar Max SR, Model 1171 Pacemaker
N) CPI Pulsar SSI Pacemaker
O) CPI Pulsar VDD Pacemaker
P) Discovery II DDD
Q) Discovery II DR
R) Discovery II SR
S) Discovery II SSI
T) Pulsar Max II Pacemaker DDDR
U) Pulsar Max II Pacemaker SSIR
W) CPI Pulsar SR Pacemaker - Recall Posting Date
- 2005-08-08
- Manufacturer
- Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant
- Recall Start Date
- 2005-07-19
- Recall Number
- 28650
- Hazard Classification
- Type I
- Model or Catalog #
- A) 1241
B) 1273, 1274, 1275
C) 1174, 1175
D) 976
E) 1276
F) 1176
G) 476
H) 970
I) 972
J) 1272
K) 1270
L) 1170
M) 1171
N) 470
O) 870
P) 981
Q) 1283, 1284, 1285, 1286
R) 1184, 1186, 1187
S) 481
T) 1280
U) 1180, 1181
W) 1172 - Lot or Serial #
- A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
I) N/A
J) N/A
K) N/A
L) N/A
M) N/A
N) N/A
O) N/A
P) N/A
Q) N/A
R) N/A
S) N/A
T) N/A
U) N/A
W) N/A - Reason for Recall
- Hermetic sealing component may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker Case late in the device's service life.
- Trade Name
- A) Homechoice Automated PD System
B) Homechoice Pro Automated PD System - Recall Posting Date
- 2005-08-22
- Manufacturer
- Baxter Healthcare Corporation
- Recall Start Date
- 2005-07-05
- Recall Number
- 28726
- Hazard Classification
- Type II
- Model or Catalog #
- A) 5C4471
B) 5C8310, 5C8310P, 5C8310PE - Lot or Serial #
- A) All serial numbers.
B) All serial numbers. - Reason for Recall
- Remote risk of electrical shock from screws used to secure the power entry module to the back of the panel, this module is the electrical connector where the power cord plugs into the unit.
- Trade Name
- A) Homechoice Pro PD Aut. System-Software
B) PBO Enal Link - Recall Posting Date
- 2005-07-11
- Manufacturer
- Baxter Healthcare Corporation
- Recall Start Date
- 2005-06-23
- Recall Number
- 28534
- Hazard Classification
- Type II
- Model or Catalog #
- A) R5C4532, R5C4534
B) 5M5590 - Lot or Serial #
- A) Renal Software Suite
B) Renal Software Suite - Reason for Recall
- This is a followup to the recall of April 2004 regarding an anomaly that may occur when changing the name of a medication, Baxter is now providing a cd with a software upgrade.
- Trade Name
- A) Immage Low Conc. IgA (IGALC) Reagent
B) Immage Low Conc. IgM (IGALC) Reagent - Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-04-17
- Recall Number
- 28610
- Hazard Classification
- Type III
- Model or Catalog #
- A) 447460
B) 447470 - Lot or Serial #
- A) All lots
B) All lots - Reason for Recall
- Reagents do not meet performance claim.
- Trade Name
- A) Magnetom Avanto System
B) Manetom Espree - Recall Posting Date
- 2005-09-05
- Manufacturer
- Siemens Aktiengesellschaft
- Recall Start Date
- 2005-08-18
- Recall Number
- 28779
- Hazard Classification
- Type II
- Model or Catalog #
- A) 7391167
B) 7727121 - Lot or Serial #
- A) N/A
B) 25285, 25490, 25340, 25043, 30048, 25039, 25541, 25234, 25462, 25173, 25089, 25526, 25110, 25066, 25137, 25486, 25049, 25097, 25311, 25168, 25333, 25555, 25244 - Reason for Recall
- A misalignment of the patient table may occur between the patient table assembly and the opening to the magnet bore.
- Trade Name
- A) Model 6060 Homerun Vol. Infusion Pump
B) Model 6060 Homerun Vol. Infusion Pump - Recall Posting Date
- 2005-07-11
- Manufacturer
- Baxter Healthcare Corporation
- Recall Start Date
- 2005-06-22
- Recall Number
- 28512
- Hazard Classification
- Type II
- Model or Catalog #
- A) 2M9832, 2M9832R, 60600040IR
B) 60600043, D2M9832 - Lot or Serial #
- A) All Serial Numbers
B) All Serial Numbers - Reason for Recall
- Manufacturer is issuing a notice to all users on two issues 1)specific keystrokes sequence can result in over-infusion, 2)to safeguard the security codes that allow programming pump parameters.
- Trade Name
- A) Plum A+ Infusion Pumps
B) Plum A+3 Infusion Pumps - Recall Posting Date
- 2005-09-05
- Manufacturer
- Abbott Laboratories
- Recall Start Date
- 2005-06-02
- Recall Number
- 28438
- Hazard Classification
- Type I
- Model or Catalog #
- A) N/A
B) N/A - Lot or Serial #
- A) Numerus lot numbers.
B) Numerus lot numbers. - Reason for Recall
- If battery service warning and E320 messages are not responded to appropriately, the pump may shut off during battery operation without providing adequate response time.
- Trade Name
- A) Simplastin Excel
B) Simplastin L
C) Simplastin - Excel S - Recall Posting Date
- 2005-09-05
- Manufacturer
- Biomerieux, Inc.
- Recall Start Date
- 2005-08-08
- Recall Number
- 28780
- Hazard Classification
- Type I
- Model or Catalog #
- A) N/A
B) N/A
C) N/A - Lot or Serial #
- A) 161711, 161929, 161897
B) 161750
C) 161720, 161760, 161761, 161783, 161811 - Reason for Recall
- The ISI values published in the package insert of Simplastin Excel products are incorrect for the devices: fibrometer (mechanical), option, XM and MTX (photo optic).
- Trade Name
- Abbott Corzyme
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-04-01
- Recall Number
- 28747
- Hazard Classification
- Type II
- Model or Catalog #
- 9977-24
- Lot or Serial #
- 18488M100, 15893M100, 16792M200, 10527M200, 23326M100, 19804M100
- Reason for Recall
- A study to compare the panels with a reference serum showed a difference in pei units
- Trade Name
- Access Immuno Sys Unconj Estriol Calib
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Beckman Coulter, Inc.
- Recall Start Date
- 2005-07-14
- Recall Number
- 28643
- Hazard Classification
- Type III
- Model or Catalog #
- 33575
- Lot or Serial #
- 416534
- Reason for Recall
- Device does not meet expiration claim of 12 months.
- Trade Name
- Access Immunoassay Prolactin Calibrator
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Beckman Coulter, Inc.
- Recall Start Date
- 2005-03-24
- Recall Number
- 27979
- Hazard Classification
- Type III
- Model or Catalog #
- N
- Lot or Serial #
- 419474
- Reason for Recall
- This calibrator lot will not support the open vial storage recommendations of the 2 months at 2 to 10 degrees c. This issue could effect patient results.
- Trade Name
- Access Immunoassay Unconj Estriol Calib
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-07-14
- Recall Number
- 28643
- Hazard Classification
- Type III
- Model or Catalog #
- 33575
- Lot or Serial #
- 416534
- Reason for Recall
- Does not meet expiration claim of 12 months.
- Trade Name
- ACMI Snap & Peel Introducer Sheaths
- Recall Posting Date
- 2005-08-22
- Manufacturer
- ACMI Corporation
- Recall Start Date
- 2005-06-30
- Recall Number
- 28738
- Hazard Classification
- Type III
- Model or Catalog #
- 60810BX, 61012BX
- Lot or Serial #
- 1297324D, 1312704E, 1321584E, 1325384E, 1339994F, 1344104G, 1389384K, 1394004L, 1400154M, 1419225A, 1297374D, 1312724E, 1316954E, 1321644E, 1325394E, 1336944F, 1339964F, 1344094G, 1355274H, 1350354H, 1359054H, 1364234J, 1367404J, 1372814J, 1383294K, 1412604M, 1419235A, 1427565A, 1430855B, 1441195B
- Reason for Recall
- ACMI received a report from B. Braun, manufacturer of device, that there were cracks in the hub
- Trade Name
- AMVISC
- Recall Posting Date
- 2005-08-22
- Manufacturer
- Anika Therapeutics Inc.
- Recall Start Date
- 2005-07-25
- Recall Number
- 28723
- Hazard Classification
- Type II
- Model or Catalog #
- 59051, 59081
- Lot or Serial #
- B050120B, B050510B
- Reason for Recall
- Some cannulae packaged with AMVISC and AMVISC Plus Visoelastic may have an incomplete pouch seal.
- Trade Name
- Architect System Software V2.10 & 2.11
- Recall Posting Date
- 2005-08-22
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-06-23
- Recall Number
- 28679
- Hazard Classification
- Type III
- Model or Catalog #
- 1G06-01, 7-99077-01, 99077-103
- Lot or Serial #
- All serial numbers.
- Reason for Recall
- The software calculation utilizes 17ul rather than 12 ul for the alkaline washing solution dispensed, the displayed value for volume remaining will be less than the actual amount in the bottle.
- Trade Name
- Argus Epic Camera
- Recall Posting Date
- 2005-08-22
- Manufacturer
- ADAC Laboratories, Inc.
- Recall Start Date
- 2005-07-13
- Recall Number
- 28730
- Hazard Classification
- Type II
- Model or Catalog #
- 2145-3007A
- Lot or Serial #
- A0105217, 01548B, 03338B, 00000000009701075, 00964B, 00227BC, 01922B, 01920B, 01921B, 00000000009901158, 00000000009901157, 00709B, 00000000009908167, 00000000009801107, 01525B, A03030282, 01332B, 03041B, 01333B, 03094B, 01310B, 03368B
- Reason for Recall
- Fracture was discovered on an argus fork which holds the detector.
- Trade Name
- Axiom Multistar
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Siemens Aktiengesellschaft
- Recall Start Date
- 2005-06-17
- Recall Number
- 28539
- Hazard Classification
- Type III
- Model or Catalog #
- 3772501, 3773004
- Lot or Serial #
- 1027, 1094, 1142, 1163, 1229, 1290, 1795, 1818, 1102, 1112, 1113, 1129
- Reason for Recall
- A system error may occur which results in unintended movement during examination.
- Trade Name
- Axym Anti-TPO Reagent
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-06-28
- Recall Number
- 28675
- Hazard Classification
- Type III
- Model or Catalog #
- 5F57-20
- Lot or Serial #
- 22827HN00
- Reason for Recall
- Manufacturer has identified a manufacturing error at a contract facility in which a different reagent was mistakenly packed in its place for a subset of this reagent lot.
- Trade Name
- BD DTXPlus Disposable Transducer Kit
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Becton Dickinson
- Recall Start Date
- 2005-06-29
- Recall Number
- 28624
- Hazard Classification
- Type II
- Model or Catalog #
- 682000, 682034
- Lot or Serial #
- 407032, 407104
- Reason for Recall
- Device (stopcock tap) may easily detach from the stopcock and cause leakage of the iv fluids and
- Trade Name
- Bd Unopette - RBC Osmotic Fragility Determination for Manual Methods
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Becton Dickinson
- Recall Start Date
- 2005-06-27
- Recall Number
- 28536
- Hazard Classification
- Type II
- Model or Catalog #
- 365830
- Lot or Serial #
- 5014328
- Reason for Recall
- Lot may have a problem that could cause an increased susceptibility for lysis of red cells from normal subjects. Yields uninterpretable results and causing the test results to not be generated.
- Trade Name
- Behring Nephelometer Pro Spec Analyzer
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Dade Behring Marburg GMBH
- Recall Start Date
- 2005-06-24
- Recall Number
- 28589
- Hazard Classification
- Type III
- Model or Catalog #
- 400252.1003
- Lot or Serial #
- 420926, 341237, 241226, 141169, 331087, 490129, 100215, 410745, 410737, 120753, 310622, 410720, 300392, 310624, 310667, 210615, 210582, 210579, 210613A, 110540, 210577, 210545, 110539, 400476,
- Reason for Recall
- Manufacturer has received reports that flags "l" and "h" indicating results below and above the reference range may not be correct for formula assays.
- Trade Name
- Biograph Duo LSO
- Recall Posting Date
- 2005-08-08
- Manufacturer
- CTI Pet Systems Inc.
- Recall Start Date
- 2005-07-12
- Recall Number
- 28625
- Hazard Classification
- Type III
- Model or Catalog #
- 8415957
- Lot or Serial #
- 5408-0301009
- Reason for Recall
- Under certain circumstances the system will continue to scan after an IRS function failure occurs. The system will scan only until the end of the planned sequence and then will shut off.
- Trade Name
- Bio-intact PTH (I-84) Assay
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Nichols Institute Diagnostics
- Recall Start Date
- 2005-03-25
- Recall Number
- 28457
- Hazard Classification
- Type II
- Model or Catalog #
- 62-7040
- Lot or Serial #
- 62-402622
- Reason for Recall
- Internal testing indicates that the assay does not meet the following performance specifications stated in the directional insert functional sensitivity, reproducibility, parallelism, recover and interfaces.
- Trade Name
- Cell DYN 1800 System
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-05-18
- Recall Number
- 28635
- Hazard Classification
- Type III
- Model or Catalog #
- 07H77-01
- Lot or Serial #
- 19017AY
- Reason for Recall
- The HP6122 printer will print one page correctly but may have problems printing more than one page from the data log or the Qc log when "print data log" and "print Qc log" commands are given.
- Trade Name
- Cell-DYN 4000 System
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-03-17
- Recall Number
- 28750
- Hazard Classification
- Type II
- Model or Catalog #
- 01H01-01, 01H01-03, 01H02-01, 01H02-03, 01H03-01
- Lot or Serial #
- 30268AA, 30271AA, 30455AA, 17500AA96, 30272AA, 30670AA, 287AA, 30266AA, 30403AA, 30653AA, 30654AA, 30697AA, 30416AA, 30488AA, 30665AA, 30672AA, 30615AA, 30709AA , 30712AA, 30686AA, 30683AA, 30723AA.
- Reason for Recall
- The optical platelet algorithm does not correctly gate the plto for the calibrator and the plus control and causes calibration problems and control plto results to fall outside the lower limit of assay range.
- Trade Name
- Clotting Factor 8 Deficient Plasma
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Dade Behring Marburg GMBH
- Recall Start Date
- 2005-07-01
- Recall Number
- 28642
- Hazard Classification
- Type II
- Model or Catalog #
- OTXW17
- Lot or Serial #
- 503848A, 503849E, 503850C, 503856B, 503858A, 503860D,
- Reason for Recall
- Manufacturer has determined that these lots do not demonstrate acceptable performance and patient samples may exhibit falsely high factor viii results, could lead to misdiagnosis.
- Trade Name
- Compression Hip Screw System-Lag Screw
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Smith & Nephew, Inc. Orthopaedic Division
- Recall Start Date
- 2005-04-11
- Recall Number
- 28190
- Hazard Classification
- Type III
- Model or Catalog #
- 12-1108
- Lot or Serial #
- 04LT84854
- Reason for Recall
- Chart stick label and inner tyvek pouch label state that the product is a hex screwdriver. The outside label correctly identifies the product.
- Trade Name
- Configuration Transfer Cable
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Baxter Healthcare Corporation
- Recall Start Date
- 2005-03-14
- Recall Number
- 28488
- Hazard Classification
- Type III
- Model or Catalog #
- 2M8155
- Lot or Serial #
- 50604
- Reason for Recall
- Baxter has been provided and distributed cables with incorrect dimensions on the thumbscrews that attach to the colleague pump, the thumbscrews were not manufactured to baxter specifications.
- Trade Name
- CoolGard 3000
- Recall Posting Date
- 2005-09-19
- Manufacturer
- Alsius Corporation
- Recall Start Date
- 2005-08-02
- Recall Number
- 28831
- Hazard Classification
- Type I
- Model or Catalog #
- N
- Lot or Serial #
- 465131
- Reason for Recall
- Coolgard 3000 units manufactured before April 12th, 2005, may overheat their coolant if left in a warm room, for prolonged periods in standby mode. At 44 c. Alarm will trigger and system latches.
- Trade Name
- Coulter 5C Cell Control
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Beckman Coulter, Inc.
- Recall Start Date
- 2005-03-09
- Recall Number
- 27862
- Hazard Classification
- Type III
- Model or Catalog #
- N
- Lot or Serial #
- 111220K-111224K for PN 624506, 102866K-102880K for PN 7547001, 102785K-102794K for PN 7547002, 869400F-869900F for PN 7547011, 100128K-100152K for PN 7547116, 112198K-112101K for PN 7547124, 100348K-100351K for PN 7547199
- Reason for Recall
- The recovery of the MCV parameter for the abnormal II level of coulter 5c cell control may recover values above the upper expected range limit.
- Trade Name
- Dell AC Adapter
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Sensormedics Corporation
- Recall Start Date
- 2005-03-11
- Recall Number
- 28669
- Hazard Classification
- Type III
- Model or Catalog #
- 22536, 22538
- Lot or Serial #
- N
- Reason for Recall
- Dell recalled the adapter units due to a risk of overheating which could lead to fire and electrical shock. The adapters are used in conjunction with laptops-peripheral components of vmax and sleep systems.
- Trade Name
- DIM RCRP Rev C-Reactive PRTN Flex 120TS
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Dade Behring, Inc.
- Recall Start Date
- 2005-05-25
- Recall Number
- 28487
- Hazard Classification
- Type III
- Model or Catalog #
- DF34
- Lot or Serial #
- DH5341, EG5300
- Reason for Recall
- Manufacturer has determined a stability issue with the particle reagent and may result in inability to calibrate, flagged results, imprecision of inaccuracy, QC results shift high or low, error message.
- Trade Name
- Disposable Tourniquet Cuffs
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Zimmer Orthopaedic Surgical Products
- Recall Start Date
- 2005-03-10
- Recall Number
- 28499
- Hazard Classification
- Type II
- Model or Catalog #
- 60707000100, 60707000300, 60707000400, 60707000500, 60707000600
- Lot or Serial #
- 60154121, 60171346, 60162824, 60171348, 60180450, 60171347, 60173808, 60194151, 60194152, 60188441, 60184634, 60202399, 60205580, 60208192, 60176164
- Reason for Recall
- Some units manufactured with a lower separation strength for the port-to-tube connection. The port
- Trade Name
- D-TRON Plus Adapter
- Recall Posting Date
- 2005-08-22
- Manufacturer
- Disetronic Medical Systems AG
- Recall Start Date
- 2005-07-16
- Recall Number
- 28683
- Hazard Classification
- Type I
- Model or Catalog #
- 3000803
- Lot or Serial #
- N/A
- Reason for Recall
- Incorrect function may occur within 15 min of replacing the adapter and priming the set. The drop in pressure may result in the delivery of up to 1.8 units of insulin which affects users 13 years and under.
- Trade Name
- D-TRON Plus Adapter
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Disetronic Medical Systems AG
- Recall Start Date
- 2005-07-06
- Recall Number
- 28686
- Hazard Classification
- Type II
- Model or Catalog #
- 3000803
- Lot or Serial #
- part # 3000803
- Reason for Recall
- Small percentage of adapters may drop in pressure which may result in the delivery of up to 1.8 units of insulin. This may occur within 15 minutes of replacing the adapter and priming the set.
- Trade Name
- Galileo Immuno Haematology System
- Recall Posting Date
- 2005-09-19
- Manufacturer
- Immucor Inc.
- Recall Start Date
- 2005-06-30
- Recall Number
- 28664
- Hazard Classification
- Type II
- Model or Catalog #
- 64999
- Lot or Serial #
- N
- Reason for Recall
- The immediate spin crossmatch (IS_XM) assay performed on the Galileo may not give the expected incompatible result.
- Trade Name
- Gemini GXL 6
- Recall Posting Date
- 2005-09-19
- Manufacturer
- Philips Medical Systems (Cleveland), Inc.
- Recall Start Date
- 2005-08-25
- Recall Number
- 28819
- Hazard Classification
- Type II
- Model or Catalog #
- 4535 679 72021
- Lot or Serial #
- 4004
- Reason for Recall
- An anomaly was identified in the gemini ct image reconstruction subsystem of the Gemini GXL Pet
- Trade Name
- Heartstring II Proximal Seal System
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Guidant Corporation Cardiac Surgery
- Recall Start Date
- 2005-07-07
- Recall Number
- 28623
- Hazard Classification
- Type II
- Model or Catalog #
- N
- Lot or Serial #
- N
- Reason for Recall
- Failure modes include incomplete or no Aortotomy with use of device on unaltered tissue, or incomplete Aortotomy when device is used on altered tissue (e.g. Cardioplegia hole or Aortotomy incision).
- Trade Name
- Immulite CEA
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Euro
- Recall Start Date
- 2005-05-25
- Recall Number
- 28484
- Hazard Classification
- Type II
- Model or Catalog #
- LKCE1
- Lot or Serial #
- 302, 303
- Reason for Recall
- Manufacturer has determined an adverse trend in stability which may result in significant decrease in adjustment slopes and a positive shift of 20-30% at low conc., 20% at higher conc. of patient results.
- Trade Name
- I-Stat G3+ Cartridges
- Recall Posting Date
- 2005-09-05
- Manufacturer
- I-Stat Corporation
- Recall Start Date
- 2005-08-05
- Recall Number
- 28778
- Hazard Classification
- Type III
- Model or Catalog #
- N
- Lot or Serial #
- L05048, L05088
- Reason for Recall
- Certain lots of I-stat G3+ cartridges may exhibit higher than expected rates of star-outs (***) in place of oxygen results.
- Trade Name
- ITHA52 Healing Abutments
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Implant Innovations, Inc.
- Recall Start Date
- 2005-05-18
- Recall Number
- 28369
- Hazard Classification
- Type III
- Model or Catalog #
- ITHA52
- Lot or Serial #
- 330918
- Reason for Recall
- The colour code on the label to identify the implant platform diameter was incorrect. The label has a yellow stripe instead of a blue stripe.
- Trade Name
- KyphX HV-R Bone Cement
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Kyphon Inc.
- Recall Start Date
- 2005-03-14
- Recall Number
- 27927
- Hazard Classification
- Type III
- Model or Catalog #
- N
- Lot or Serial #
- EL08304
- Reason for Recall
- US version of the instructions for use accompanied product sent to Canada.
- Trade Name
- Leveen Coaccess Electrode
- Recall Posting Date
- 2005-08-22
- Manufacturer
- Radiotherapeutics Corporation
- Recall Start Date
- 2005-08-02
- Recall Number
- 28745
- Hazard Classification
- Type II
- Model or Catalog #
- 26-216, 26-217
- Lot or Serial #
- 7108067, 6556464, 6826039, 6666258, 6556462, 7356251, 31804, 7021736, 7091462, 21403R, 6558336, 6538341, 6556258, 6538336, 7257089, 7481332
- Reason for Recall
- Manufacturer has received reports of extended ablation times, lack of roll-off, and
- Trade Name
- LH 1500 Series Lab Automation System
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-06-23
- Recall Number
- 28510
- Hazard Classification
- Type III
- Model or Catalog #
- 6605528
- Lot or Serial #
- N
- Reason for Recall
- Warnings in manual conflict with sections in the manual. Potential for mechanical and voltage hazards during maintenance.
- Trade Name
- Magnetom Avanto System
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Siemens Aktiengesellschaft
- Recall Start Date
- 2005-06-21
- Recall Number
- 28493
- Hazard Classification
- Type II
- Model or Catalog #
- 7391167
- Lot or Serial #
- 25285, 25340, 25043, 25039, 25234, 25173, 25089, 25110, 25066, 25137, 25049, 25097, 25311, 25168, 25333, 25224
- Reason for Recall
- For the safety of the service technicians, the acc power connection X102 need to be checked and labelled.
- Trade Name
- Microstrep Plus 1
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Dade Behring, Inc.
- Recall Start Date
- 2005-06-23
- Recall Number
- 28563
- Hazard Classification
- Type III
- Model or Catalog #
- B1027-201
- Lot or Serial #
- 2005-08-06, 2006-01-14, 2006-01-25, 2006-02-24
- Reason for Recall
- There is a potential for out of range (high) quality control Clindamycin results for ATC'S. pneumoniae 49619 and
- Trade Name
- MISYS Laboratory System
- Recall Posting Date
- 2005-07-11
- Manufacturer
- MISYS Healthcare Systems Inc.
- Recall Start Date
- 2005-05-13
- Recall Number
- 28491
- Hazard Classification
- Type I
- Model or Catalog #
- SQI-MIC-SY
- Lot or Serial #
- LARS versions 5.3 or later
- Reason for Recall
- In rare situations, modification of previously reported specimen results using the lars application, may modify other previously filed results on the same specimen.
- Trade Name
- MISYS Laboratory System Blood Bank
- Recall Posting Date
- 2005-08-08
- Manufacturer
- MISYS Healthcare Systems Inc.
- Recall Start Date
- 2005-05-10
- Recall Number
- 28492
- Hazard Classification
- Type III
- Model or Catalog #
- N
- Lot or Serial #
- Sites using software ver. 6.1
- Reason for Recall
- CORRECTION TO RECALL # 28492 PREVIOUSLY POSTED ON 2005-07-11.
Information entered into the comment field may be lost when resulting the blood type for the first time via a blood bank instrument interface. The software problem will be corrected with the installation of a software patch.
- Trade Name
- MISYS Laboratory System Blood Bank
- Recall Posting Date
- 2005-07-11
- Manufacturer
- MISYS Healthcare Systems Inc.
- Recall Start Date
- 2005-05-10
- Recall Number
- 28492
- Hazard Classification
- Type III
- Model or Catalog #
- N
- Lot or Serial #
- Sites using software ver. 6.1
- Reason for Recall
- When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more susceptibilities may be deleted.
- Trade Name
- Multileaf Collimater (MLC)+Software
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Varian Medical Systems, Inc.
- Recall Start Date
- 2005-07-01
- Recall Number
- 28682
- Hazard Classification
- Type II
- Model or Catalog #
- N
- Lot or Serial #
- H520003-H520943
H530012-H534223
H540381-H549004 - Reason for Recall
- Potential mistreatment may occur because initial MLC shape may be an open field and not match planned MLC field when executing dynamic MLC treatment types.
- Trade Name
- One Touch UltraSmart Meter
- Recall Posting Date
- 2005-08-22
- Manufacturer
- Lifescan Inc.
- Recall Start Date
- 2005-06-15
- Recall Number
- 28489
- Hazard Classification
- Type III
- Model or Catalog #
- 011-555, 020-720
- Lot or Serial #
- All lots.
- Reason for Recall
- Glucose meter does not prompt user to take a snack at glucose levels over the entire range of 1.1MMOL
- Trade Name
- One Touch UltraSmart Meter
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Lifescan Inc.
- Recall Start Date
- 2005-06-15
- Recall Number
- 28489
- Hazard Classification
- Type III
- Model or Catalog #
- 011-555, 020-720
- Lot or Serial #
- All lots.
- Reason for Recall
- CORRECTION TO RECALL # 28489 PREVIOUSLY POSTED ON 2005-08-22.
Labelling incorrectly states that the 'snack' message will appear on .Meter between 1.1mmol/l to 3.9 mmol/l, labelling should state between 1mmol/l to 3.3 mmol/l.
- Trade Name
- Paragon CZE 2000 Software Version 2.0
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-07-27
- Recall Number
- 28734
- Hazard Classification
- Type III
- Model or Catalog #
- A09744
- Lot or Serial #
- N
- Reason for Recall
- Potential for incorrect results to be displayed and printed out.
- Trade Name
- Prisma Continuous Replacement System
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Gambro Dasco S.P.A.
- Recall Start Date
- 2005-08-16
- Recall Number
- 28774
- Hazard Classification
- Type I
- Model or Catalog #
- N
- Lot or Serial #
- N
- Reason for Recall
- Serious injuries or deaths have resulted because of excessive ultrafiltration. This can occur when the cause of the "incorrect weight change detected" alarm is not identified and removed by the user. « incorrect weight change detected
- Trade Name
- Prismaflex Software 1.07.3 KJ
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Gambro Dasco S.P.A.
- Recall Start Date
- 2005-05-27
- Recall Number
- 28506
- Hazard Classification
- Type II
- Model or Catalog #
- 6023014700
- Lot or Serial #
- All serial numbers
- Reason for Recall
- Pumps may stop while green light is on with no audible alarm. No hemodynamic problems but access eventually clot as well as lost blood in set.
- Trade Name
- Purevision Toric Tinted Contact Lenses
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Bausch & Lomb Inc.
- Recall Start Date
- 2005-06-13
- Recall Number
- 28497
- Hazard Classification
- Type II
- Model or Catalog #
- 738
- Lot or Serial #
- W58405708, W58405713
- Reason for Recall
- Portion of two Purevision Toric product lots did not complete the required cycle time in the extraction and hydration process. As a result, residual extractable in the lenses exceeded specification.
- Trade Name
- Pyramidal Tip Obturator
- Recall Posting Date
- 2005-09-19
- Manufacturer
- Keir Surgical Ltd.
- Recall Start Date
- 2005-08-09
- Recall Number
- 28751
- Hazard Classification
- Type I
- Model or Catalog #
- KS81-1055
- Lot or Serial #
- KS81-1055
- Reason for Recall
- Distal tip of obturator, lot# 10123, separated from the proximal shaft. A recent affected device was found after initial company recall done on April 2002.
- Trade Name
- Quicklyte Sensor Cartridge
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Dade Behring, Inc.
- Recall Start Date
- 2005-06-17
- Recall Number
- 28555
- Hazard Classification
- Type III
- Model or Catalog #
- S600
- Lot or Serial #
- 5CD813, 5CD816, 5DD817, 5DD8120
- Reason for Recall
- Manufacturer has confirmed that urine chloride test results in patients, qc and proficiency survey samples may be elevated by 10-15%.
- Trade Name
- Remisol 2000 Data Manager System
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-06-27
- Recall Number
- 28505
- Hazard Classification
- Type III
- Model or Catalog #
- A27343
- Lot or Serial #
- N
- Reason for Recall
- Results may upload with an incorrect or blank sample ID.
- Trade Name
- Scissors Insert for Single Use
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Richard Wolf GMBH
- Recall Start Date
- 2005-04-29
- Recall Number
- 28206
- Hazard Classification
- Type II
- Model or Catalog #
- 8392.0403, 8393.0403, 8394.0403
- Lot or Serial #
- 953046, 9532217, 953486
- Reason for Recall
- Damage to the insulation part may arise by unintentional "jamming" of the scissor on the existing edges in the access instrument when being introduced or pulled out. Insulation material may come off and fall.
- Trade Name
- Set Radical Handheld Pulse Oximeter
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Masimo Corporation
- Recall Start Date
- 2005-06-13
- Recall Number
- 28558
- Hazard Classification
- Type II
- Model or Catalog #
- N
- Lot or Serial #
- Less than or equal to 102999 - P3027 through P3148
- Reason for Recall
- The internal speaker could fail to produce an audio alarm during an alarm condition. The affected units were manufactured prior to December 11, 2001.
- Trade Name
- Six-Part Bar Code Labels, Sarstedt Tubes
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Roche Molecular Systems, Inc.
- Recall Start Date
- 2005-05-17
- Recall Number
- 28326
- Hazard Classification
- Type I
- Model or Catalog #
- N
- Lot or Serial #
- 28868, 029213
- Reason for Recall
- Rolls of six-part bar code labels, roche M
- Trade Name
- Sonoline Antares Diagnostic Ultrasound
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Recall Start Date
- 2005-06-05
- Recall Number
- 28540
- Hazard Classification
- Type II
- Model or Catalog #
- 5936518
- Lot or Serial #
- 112607, 112593, 112609, 112611, 112530, 112595, 112612, 112687, 112610, 10077, 10145, 10280, 111223, 111233, 111234, 112579, 10438, 111197, 112736, 10068, 111843, 111922, 111923, 111639, 111643, 111660, 111666, 10928, 11092, 11096, 112658, 112666, 10838, 10925, 112237, 10134, 112267, 112070, 112073, 10940, 111166
- Reason for Recall
- Error occurs after performing a labeled measurement on a frozen waveform utilizing a 2d image and an angle-corrected pulse wave doppler waveform.
- Trade Name
- STAAR Surgical STAARVISC II
- Recall Posting Date
- 2005-08-22
- Manufacturer
- STAAR Surgical Company
- Recall Start Date
- 2005-07-18
- Recall Number
- 28728
- Hazard Classification
- Type II
- Model or Catalog #
- N
- Lot or Serial #
- B041118C
- Reason for Recall
- The cannula package has not been validated to a sterility assurance level (sal) of 0.000001 and therefore the sterility can not be assured.
- Trade Name
- STAGO ATA R System
- Recall Posting Date
- 2005-08-22
- Manufacturer
- Diagnostica Stago
- Recall Start Date
- 2005-06-08
- Recall Number
- 28662
- Hazard Classification
- Type III
- Model or Catalog #
- 57160
- Lot or Serial #
- All serial numbers.
- Reason for Recall
- Manufacturer determined there is potential defect relating to change of disposable cuvette roll change, filled cuvettes may wait on the conveyer belt prolonging contact time with plasma & intermediate regent.
- Trade Name
- StemCXP Software Version 1.0
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-06-09
- Recall Number
- 28471
- Hazard Classification
- Type III
- Model or Catalog #
- 628843
- Lot or Serial #
- N
- Reason for Recall
- 7HPCSA and 7HPCSA control protocols may not invoke the algorithm under certain conditions.
- Trade Name
- Swiss Lithoclast Ultrasound Handpiece
- Recall Posting Date
- 2005-07-25
- Manufacturer
- Electro Medical Systems (EMS) SA
- Recall Start Date
- 2005-06-17
- Recall Number
- 28544
- Hazard Classification
- Type II
- Model or Catalog #
- FR-093
- Lot or Serial #
- 20124, 20172, 20268, 29342, 20372, 20403, 20406
- Reason for Recall
- Manufacturer has become aware that handpieces have twisted cables and there is a small possibility that they may not function properly or the function may diminish over time.
- Trade Name
- Synchron Clinical Sys. Alcohol Reagent
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Beckman Coulter, Inc.
- Recall Start Date
- 2005-05-17
- Recall Number
- 28371
- Hazard Classification
- Type III
- Model or Catalog #
- 91DIC
- Lot or Serial #
- UPDATED RECALL # 28371 PREVIOUSLY POSTED ON 2005-06-27.
M405028, M409024, M407255, M412090, M503108 - Reason for Recall
- Reagent is past expiry date thus will not produce results since it cannot calibrate successfully.
- Trade Name
- Synchron CRP
- Recall Posting Date
- 2005-09-19
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-07-18
- Recall Number
- 28832
- Hazard Classification
- Type II
- Model or Catalog #
- N
- Lot or Serial #
- N
- Reason for Recall
- Synchron CRP turbidimetric assay may not be sensitive or specific enough as a sole diagnostic marker of infection in neonates.
- Trade Name
- Synchron Systems Amphetamine Reagent
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Beckman Coulter Inc.
- Recall Start Date
- 2005-07-07
- Recall Number
- 28607
- Hazard Classification
- Type III
- Model or Catalog #
- 475000
- Lot or Serial #
- M501225, M503380
- Reason for Recall
- These lots have different than expected cross reactivities. May cause false positive amphetamine results in patients taking medications containing ephedrine.
- Trade Name
- TDX
- Recall Posting Date
- 2005-08-08
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-04-05
- Recall Number
- 28653
- Hazard Classification
- Type III
- Model or Catalog #
- 9797-02, 9797-12
- Lot or Serial #
- 18229Q100, 18230Q100
- Reason for Recall
- Manufacturer has discovered a change in performance in which patient results are depressed 5-8%, elevated values when running a calibration curve.
- Trade Name
- Testpack Plus HCG Combo with OBC
- Recall Posting Date
- 2005-09-05
- Manufacturer
- Abbott Laboratories Diagnostic Division
- Recall Start Date
- 2005-03-22
- Recall Number
- 28752
- Hazard Classification
- Type II
- Model or Catalog #
- 7B34-16
- Lot or Serial #
- 16006M200, 19199M300
- Reason for Recall
- Manufacturer has received user complaints reporting occurrences of false positive results or weak positive colour on the patient bar for specimens where the results disagree with other methods.
- Trade Name
- Viewforum Software
- Recall Posting Date
- 2005-07-11
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Recall Start Date
- 2005-05-27
- Recall Number
- 28501
- Hazard Classification
- Type II
- Model or Catalog #
- M1M1171
- Lot or Serial #
- 5V9371J, 00F1F8B16DA, 00F1F9385CE
- Reason for Recall
- The "automated analysis of vascular obstruction" tool in the Viewforum 2003 software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
