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A Letter To LifeScan Customers: URGENT: MEDICAL DEVICE RECALL OneTouch® Ultra® Test Strips LifeScan, Inc. Voluntary Product Removal and Replacement January 30, 2006 If you use, recommend, distribute or sell OneTouch® Ultra® Test Strips, we want to make you aware that LifeScan is voluntarily removing and offering to replace OneTouch Ultra Blood Glucose Test Strips in 100-count packages with a lot number of 2609684 and those in 50-count packages with a lot number of 2600318. LifeScan is replacing these two lots of OneTouch Ultra Test Strips because they did not undergo all of our manufacturing release steps. Other than not completing these prescribed steps, the test strips in these two lots passed all performance requirements, and should not pose any harm to people testing with them. Nevertheless, LifeScan is asking customers to return product from Lots 2609684 and 2600318 and requesting users not to test any further with remaining strips from these two lots. LifeScan will provide replacement product.
Please check the lot numbers of any OneTouch Ultra Test Strips in your possession. The lot number appears on the outside of the test strip box and on the label of the test strip vial. If you do not have any OneTouch Ultra Test Strips from either lot 2609684 or lot 2600318, then your test strips are not subject to this recall. How To Return the Affected Test Strips andReceive Replacement OneTouch Ultra Test Strips How To Contact LifeScan
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