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Urgent Medical Device Correction: OneTouch® Ultra® Test Strips

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February 4, 2010

Dear Valued Customer:

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 does not meet 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.

OneTouch Ultra Test StripsWe have recently determined that up to 900 OneTouch® Ultra® Test Strip Packages contain vials of the wrong test strip. These incorrect test strips can be easily identified because they are dark blue and don’t have a brand name printed on the strip (See Picture 1). As a safety feature, these strips will not turn on your OneTouch®Ultra® Brand meter or provide a test result.

These mislabeled test strips are found only in 100-count packages (4 vials of 25 test strips each) of OneTouch Ultra Test Strips with Lot # 2964512. All other 25-, 50- and 100-count packages of OneTouch Ultra Test Strips are unaffected.

Our priority is to make sure you have only OneTouch Ultra Test Strips so that you can test your blood glucose with confidence as recommended by your healthcare professional.

  1. Please check your OneTouch Ultra Test Strips to see if you have any test strips from lot # 2964512. The lot number can be found on both the vial label and the outer carton (Picture 2). If you have any test strips from this lot, please compare the test strips in each vial with the strips in Picture 1 to confirm they are OneTouch Ultra Test Strips.
  2. Lot Number Location If you discover any mislabeled test strips, do not try to use them. Please click below for further instructions to receive replacement product free of charge.

If your OneTouch® Ultra® Test Strips do not have the affected lot, you can continue using the strips. Only strips from lot number 2964512 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.

We apologize for any inconvenience this issue may cause and have already taken steps to prevent it from recurring in the future. Thank you for your continued support of LifeScan.

Sincerely,
LifeScan Customer Service

Please note our current Customer Service Hours are 5:00 a.m. - 7:00 p.m. PT, 7 days a week.

Click here if you have any mislabeled strips


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The health information on this Web site is for general background purposes and is not a substitute for medical advice or treatment for specific conditions. Seek prompt medical attention for health care questions you have. Consult your physician before making changes to your medication, diet, fitness program, or blood glucose testing schedules.