FDA UPDATES ALERT ON FAKE BLOOD GLUCOSE STRIPS

FEBRUARY 01, 2007

New lot numbers have been added to the recall of LifeScan's OneTouch (Basic/Profile) Test Strips. Although no new numbers have been added, the recall also still affects OneTouch Ultra Test Strips.

The FDA has classified the current situation as a Class 1 recall because some of the counterfeit products have major deviations in performance. LifeScan personnel examined the counterfeit strips and found erratic test results that do not meet the company's performance specifications. The counterfeit test strips are as follows: OneTouch Ultra Test Strips in lot numbers 2691191 and 2691261 and OneTouch (Basic/Profile) Test Strips in lot numbers 2662169 and 227078A (new additions), 2606340, 2619932, 272894A, and 2615211.

LifeScan has asked pharmacy personnel and retailers to routinely check their inventory of 50-count OneTouch Ultra and OneTouch (Basic/Profile) Test Strips. Any counterfeit test strips should be reported to LifeScan by calling 866-247-0264. For more information, visit www.lifescan.com.




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