Update October 23, 06

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Update October 23, 06

October 23^rd: FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips

On October 13, 2006, the U.S. Food and Drug Administration (FDA) alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. These test strips are used by people with diabetes to measure their blood glucose. Today's announcement provides two additional lot numbers that are included in the distribution of counterfeit products, along with descriptions of how to identify them.

The counterfeit test strips are:

* One Touch Basic®/Profile® (lot #272894A, 2619932, 2606340, and 2615211 (new)) test strips; and,
* One Touch Ultra® (lot #2691191 and 2691261 (new)) test strips.

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.

LifeScan alerted FDA of the counterfeit test strips. The FDA continues to investigate the matter, including whether there have been any adverse events associated with this counterfeit product.

Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact Lifescan, Inc. at 1-866-621-4855. Consumers who have discarded the outer box or do not know the lot number of their test strips should stop using those test strips and replace them.
The counterfeit test strips were distributed to pharmacies and stores nationwide by various distributors.

For the complete review of this update, Please follow http://www.fda.gov/bbs/topics/NEWS/2006/NEW01490.html

For any questions about this article, please Email Romil Rambhia at romil@mdiconsultants.com

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