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U.S. Department of Health and Human Services

Safety

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LifeScan One Touch Blood Glucose Test Strips -- Counterfeit Alert

Audience: Pharmacists, other healthcare professionals and patients

[UPDATE 03/12/2007] Class I Recall expanded to include additional lot numbers of the One Touch Ultra (2691261) and Basic/Profile Blood Glucose Test Strips (2615211 and 227078A).

[UPDATE 02/06/2007] Matrix Distributors Inc. added as recalling firm.

[UPDATE 12/12/2006] Recall classified as Class I because use of the counterfeit products could cause serious injury or death. Recall includes One Touch Basic/Profile Blood Glucose Test Strips (Lot Numbers 272894A, 2619932, 2606340 50-count packages) and One Touch Ultra Blood Glucose Test Strips, LifeScan [lot Numbers 2691191, 50-count test strips (2 vials of 25 test strips)].

[UPDATE 10/24/2006] FDA provided two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.

[Posted 10/13/2006] LifeScan and FDA notified healthcare professionals and the public of counterfeit blood glucose test strips being sold in the United States for use with various models of the One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose. The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death.

[December 12, 2006 - Recall Notice One Touch Ultra Blood Glucose Test Strips - FDA]
[December 12, 2006 - Recall Notice One Touch Basic/Profile Blood Glucose Test Strips - FDA]
[October 23, 2006 - News Release - FDA]
[October 13, 2006 - News Release - FDA]