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Important safety information concerning OneTouch Ultra Test Strips - For Health Professionals
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(PDF Version - 275 K)Contact MHPD_DPSC
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.
URGENT PRODUCT NOTIFICATION
April 30, 2007
Dear Health Care Professional,
You may have patients who have a OneTouch® Brand Blood Glucose Monitor that works with OneTouch® Ultra® Test Strips, or you and your staff may use these products in your clinic. We want to make you aware of the following:
A very small number of OneTouch Ultra Test Strip 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®, 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.
Please Advise Patients and Staff Not To Use OneTouch Ultra Test Strips From Damaged Vials - Call LifeScan
- Your patients and staff should inspect their OneTouch Ultra Test Strips for holes or other damage in the vial.
- Patients and staff should not use any test strips from vials that have a hole or any other damage. Instead, they should immediately report damaged vials to LifeScan Customer Service by calling us toll-free, 1 866 395-2977 (Mon.-Fri., 9:00am to 8:00pm ET). A Customer Service Representative will be available to help and provide instructions.
- If patients or staff have OneTouch Ultra Test Strip vials that are not damaged, they can continue to use the test strips to test blood glucose.
To assist you in communicating this issue to your patients and colleagues, we are enclosing a copy of the letter that LifeScan is mailing throughout Canada to registered users of our OneTouch Ultra Test Strips. Please forward this information to anyone you know who uses these test strips.
LifeScan takes this issue very seriously and has taken steps to prevent this problem in the future. In addition, Health Canada has been notified of this issue and of the steps LifeScan has taken to solve it.
We apologize for any inconvenience this may cause you and your patients. If you have any questions about OneTouch Ultra Test Strips, please call our Customer Service Line at 1 866 395-2977. Thank you for your continued support of LifeScan.
#300 - 4170 Still Creek Drive,
Burnaby, B.C. V5C 6C6
Tel: 1-866-395-2977
www.OneTouch.ca
Any suspected adverse reaction 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
Sincerely,
original signed by
Les Klajnscek
President, LifeScan Canada Ltd.
Trademarks owned by Johnson & Johnson and used under license. ©2007 LifeScan Canada Ltd. AW 088-879A 04/07
