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November 23, 2009

At LifeScan we hold our products to the highest standards of quality; constantly working to ensure they provide glucose results you can rely on. For that reason, we're also committed to communicating with you when we learn of product that may not be performing to our expected standards.

If you use the One Touch® Ultra® Test Strips, have patients who use them or distribute the OneTouch® Ultra® Test Strips, please take note of the following issue. We have recently determined that two lots of 100 count OneTouch® Ultra® Test Strips may contain a small number of damaged test strip containers (also called ‘vials’). These test strips were sold in 100-count packages containing 4 vials of 25 test strips each.

The defect in the bottom of the vial (See Figure 1) does not penetrate the inner portion of the vial which contains the test strips. Due to the fact that the test strips are not exposed, performance of the test strips is not impacted when vials are stored and used as instructed.

We estimate that less than 25 damaged vials are among all the test strips in the two lots that have been identified as having this issue in the U.S.

Only 100-count OneTouch® Ultra® Test Strips (sold as 4 vials of 25 test strips each) with lot numbers 2960566 and 2960878 are included in this notice. The lot number can be found on both the vial label and the outer carton.

If your OneTouch® Ultra® Test Strip vials do not have the defect in the bottom of the vial, you can continue using the strips with confidence in the blood glucose results you are receiving. Only strips with the defect in the bottom of the vial and from the lot numbers 2960566 and 2960878 are affected.

Also if you use a meter other than the OneTouch® Ultra®, OneTouch® UltraSmart®, OneTouch® Ultra®2, OneTouch® Ultramini®, OneTouch® UltraLink™, and/or the Induo® Systems your strips have not been affected by this notification.

Click here if you have a damaged vial within the affected lots

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