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Important safety information concerning OneTouch® Ultra® Test Strips - LifeScan Canada Ltd.
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(PDF Version - 122 K)Contact: Marketed Health Products Directorate (MHPD)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from LifeScan Canada Ltd.
Contact the company for a copy of any references, attachments or enclosures.
Public Communication
Health Canada Endorsed Important Safety Information on
OneTouch® Ultra® Test Strips
Urgent Product Notification
OneTouch® Ultra® Test Strips
May, 2007
Dear LifeScan Customer:
Our records show that you may have a OneTouch® Brand Blood Glucose Monitor that works with OneTouch® Ultra® Test Strips. We want to make you aware of the following:
A very small number of OneTouch Ultra Test Strip containers (also called "vials") may contain a hole on the side (see photos below). This kind of damage to the vial can affect the test strips inside and lead to error messages or blood glucose results that are too high or too low.
These test strips are used with the OneTouch® Ultra®, OneTouch® Ultra®2, OneTouch® UltraSmart®, OneTouch® UltraMini™, and InDuo® Systems. A closed test strip vial is designed to create a seal to keep out air and moisture. A test strip vial with a hole could allow air or moisture into the vial, which could harm the test strips.
Do Not Use OneTouch Ultra Test Strips From Damaged Vials - Call LifeScan
Inspect your OneTouch Ultra Test Strip vials for holes or other damage.
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Do not use any test strips from vials that have a hole or any other damage. Immediately report damaged vials to LifeScan Customer Service by calling us toll-free at 1 866 395-2977 (Mon. - Fri., 9:00am to 8:00pm ET). A representative will be available to help you and provide instructions.
- If your OneTouch Ultra Test Strip vials are not damaged, you can use the test strips to test your blood glucose as directed by your health care professional.
LifeScan takes this issue very seriously and has taken steps to prevent this problem in the future. If you have any questions about your OneTouch Ultra Test Strips or OneTouch Brand Blood Glucose Monitor, please call us toll-free at 1 866 395-2977.
LifeScan Canada Ltd.
#300 - 4170 Still Creek Drive,
Burnaby, B.C. V5C 6C6
Tel: 1-866-395-2977
www.OneTouch.ca
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: 613-954-6522
Fax: 613-952-7738
We apologize for any inconvenience this may cause you, and thank you for your continued support of LifeScan.
Sincerely,
original signed by
Les Klajnscek
President, LifeScan Canada Ltd.
P.S. If you no longer use a OneTouch Brand Blood Glucose Monitor, please call us at 1 866 395-2977 to update your record to avoid receiving these notifications in the future.
Trademarks owned by Johnson & Johnson and used under license. ©2007 LifeScan Canada Ltd. AW 088-877A 05/07
