Alert on counterfeit One Touch Basic/Profile and One Touch ultra test strips

FDA Consumer, Nov-Dec, 2006

The FDA is alerting the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan Inc. One Touch 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. No injuries have been reported to the FDA to date.

The counterfeit test strips are

* One Touch Basic/Profile (lot number 272894A, 2619932, or 2606340) test strips

* One Touch Ultra (lot number 2691191) test strips.

Consumers who have the counterfeit test strips should stop using them, replace them immediately, and contact their physician. Consumers with questions may contact the company at (866) 621-4855.

The counterfeit test strips were distributed to pharmacies and stores nationwide--but primarily in Ohio, New York, Florida, Maryland, and Missouri--by Medical Plastic Devices Inc., Quebec, and Champion Sales Inc., Brooklyn, N.Y.

The counterfeit test strips can be identified by the following characteristics:

Counterfeit One Touch Basic/Profile Test Strips

* Lot number 272894A, 2619932, or 2606340

* Multiple languages--English, Greek, and Portuguese text on the outer carton

* Limited to 50-count One Touch Basic/Profile Test Strip packages.

Counterfeit One Touch Ultra Test Strips

* Lot number 2691191

* Multiple languages--English and French text on the outer carton

* Limited to 50-count One Touch Ultra Test Strip packages.

LifeScan alerted the FDA to the counterfeit test strips. The agency is investigating the matter.

LifeScan is alerting the public via a press release and is notifying pharmacists, distributors, and wholesalers through a letter. In its letter, the company is advising customers to contact their original source of supply for restitution. Visit www.GenuineOneTouch. com for more information.

The FDA is alerting its Counterfeit Alert Network partners, a coalition of health care professional, consumer, and trade associations, which have agreed to further disseminate this important information in a timely and effective manner.

Any adverse reactions experienced with the use of this product, and quality problems, should also be reported to the FDA's MedWatch Program by telephone at (800) 332-1088, by fax at (800) 332-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or through the MedWatch Web site at www.fda.gov/ medwatch