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 A Letter To OneTouch® Ultra® Test Strip Customers: -- Urgent Product Recall: Incorrect Control Solution Range Printed On 1 Lot Of 50-Count OneTouch® Ultra® Test Strips Sold In The U.S. -- January 20, 2004 If you use OneTouch® Ultra® Test Strips to test your blood glucose, have patients who use them, or distribute and sell OneTouch® Ultra® Test Strips to customers, please read the following important information. LifeScan is voluntarily removing a single lot of 50-Count OneTouch® Ultra® Test Strips. The lot number of the affected test strips is # 1022859. No other OneTouch Ultra Test Strips or any other OneTouch products are affected by this action. LifeScan has determined that the Control Solution Range was printed incorrectly on the vial label of 1 lot of 50-count OneTouch Ultra Test Strips sold in the United States. The control solution range for these strips was incorrectly printed as 97-131 mg/dL (5.4-7.3 mmol/L) instead of the correct range of 111-150 mg/dL (6.2-8.3 mmol/L). The quality and functionality of the test strips is not affected, this is a printing error only in the control solution range. How To Identify Test Strips With Incorrectly Printed Control Solution RangePlease compare the lot number of all OneTouch Ultra Test Strips in your possession with the lot number of the affected test strips listed below. If you have test strips from this affected lot, please be sure to use the corrected control solution range of 111-150 mg/dL (6.2-8.3 mmol/L) when conducting control solution tests with these test strips.
If you have the affected product, please contact LifeScan for return and replacement instructions. OneTouch® Ultra® Control Solution is used to check that the meter and the test strips are working together as a system and that you are performing the test correctly. It is very important that you routinely perform this simple test to make sure you get an accurate result. Please refer to your meter's Owner's Booklet for more information regarding when and how to conduct control solution tests. If you have any questions about this notice or the use of OneTouch Brand products, please contact LifeScan in one of the following ways: How To Contact LifeScan
We apologize for any inconvenience this issue may cause. Thank you for your continued support. |
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