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 A Letter To OneTouch® Ultra® Test Strip Customers: -- Urgent: Broken Rims On Some OneTouch Ultra Test Strip Vials May Affect Blood Glucose Results -- March 25, 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, please be aware: The rim on some OneTouch Ultra Test Strip vials may become broken or cracked and lead to error messages or blood glucose results that are higher than expected. These strips are packaged in flip top vials (see Diagram 1) and are used with the OneTouch Ultra, OneTouch® UltraSmart®, and InDuo® Systems to measure blood glucose levels. LifeScan has received reports from some customers that the top edge of the vial rim under the flip top is cracked or broken (see Diagram 2). The flip top is designed to snap down over the vial rim creating a seal that keeps out air and moisture. Because a broken or cracked rim on a test strip vial can cause the test strips to produce an error message or blood glucose result that is higher than expected, customers should not use OneTouch Ultra Test Strips that are packaged in broken or cracked vials.
Do Not Use OneTouch Ultra Test Strips From Vials With Broken or Cracked Rims - Call LifeScan The number of OneTouch Ultra Test Strip vials found to be broken or cracked appears to be extremely limited. If, however, you open a vial that has a broken or cracked rim, do not use the test strips. Immediately contact LifeScan at 888 849-7383. LifeScan takes this issue very seriously and a correction has been put in place to address the manufacturing process to prevent broken or cracked vials. In addition, the U.S. Food and Drug Administration has been notified of this situation and the steps that LifeScan has taken to resolve it. We apologize for any confusion or inconvenience this issue may cause. Thank you for your continued support of LifeScan. How To Contact LifeScan Regarding Broken or Cracked Test Strip VialsCall LifeScan's toll-free, 24-hour Customer Service Line: 888 849-7383.
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