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Urgent Medical Device Correction: OneTouch® Ultra® Test Strips 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.
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.
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, 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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