April 23, 2007

If you use OneTouch® Ultra® Test Strips to test your blood glucose, have patients who use them, or distribute or sell OneTouch Ultra Test Strips, please be aware: A very small number of OneTouch Ultra Test Strip containers (also called "vials") may contain a hole on the side (see photos).

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® UltraMini™, OneTouch® UltraSmart®, and InDuo® Systems to measure blood glucose levels. 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. As a reminder, your test strips should always be stored in the original vial, with the lid closed.

Do Not Use OneTouch Ultra Test Strips From Damaged Vials- Call LifeScan
The number of OneTouch Ultra Test Strip vials found to have a hole appears to be extremely limited. If, however, you find a vial that has a hole or is otherwise damaged, do not use the test strips. Immediately contact LifeScan.

If 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. In addition, the U.S. Food and Drug Administration has been notified of this issue and of the steps LifeScan has taken to resolve it.

We apologize for any inconvenience this may cause. Thank you for your continued support of LifeScan.

How To Contact LifeScan

People with diabetes
Telephone: 800 845-2561 (For all other countries, see Around the World.)

Health Care Professionals
Telephone: 800 845-4304 (For all other countries, see Around the World.)

Retailers/Distributors:
Telephone: 800 845-9821 (For all other countries, see Around the World.)

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