Oct 20, 2006

Public Warned About Fake OneTouch Test Strips

Tara Dairman

The U.S. Food and Drug Administration (FDA) is alerting people with diabetes to watch out for counterfeit blood glucose test strips intended for use with various models of LifeScan’s OneTouch blood glucose meters. While this announcement was originally made last Friday, October 13, additional lots of counterfeit test strips have been discovered over the past few days.

The counterfeit strips can be identified by lot number and certain other characteristics. The counterfeits are:

OneTouch Ultra lot numbers 2691191 and 2691261:

• English and French text on the outer carton
• Limited to 50-Count OneTouch Ultra Test Strip packages

OneTouch Basic/Profile lot numbers 272894A, 2619932, and 2606340:

• English, Greek, and Portuguese text on the outer carton
• Limited to 50-Count OneTouch Basic/Profile Test Strip packages

OneTouch Basic/Profile lot number 2615211:

• English text on the outer carton
• Limited to 50-Count OneTouch Basic/Profile Test Strip packages
• Test strips labeled as plasma-calibrated (vertical text on side of vial)

OneTouch FastTake and OneTouch SureStep test strips have not been affected.

The phony strips were distributed to pharmacies and stores nationwide but have been found primarily in Ohio, New York, Florida, Maryland, and Missouri. They were distributed by two companies: Medical Plastic Devices, Inc., of Quebec, Canada, and Champion Sales, Inc., of Brooklyn, New York.

These test strips could provide incorrect blood glucose values, leading people to take too much or too little insulin or other diabetes drugs, a situation that could lead to serious injury or death. So far, no injuries have been reported to the FDA.

If you discover that you have of a batch of counterfeit test strips, stop using them immediately and replace them with genuine strips. You are also encouraged to call LifeScan at (800) 227-8862 and to report the incident to the FDA's MedWatch Program at (800) FDA-1088. The MedWatch Program can also be contacted via the Internet at www.fda.gov/medwatch.

More details and links to pictures of the fake strips can be found in this press release on LifeScan's Web site. LifeScan is a subsidiary of Johnson & Johnson.

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