Glucose Test Strips Recalled
Too-High Readings With Some Contour TS Blood Glucose Meter Test Strips
Dec. 26, 2007 -- Test strips for a Bayer blood-glucose meter give too-high readings and are being recalled, the FDA announced today.
The voluntary recall affects test strips made specifically for Bayer's Contour TS Blood Glucose Meter. It does not involve test strips for other Bayer meters, including the Ascensia Contour and the Ascensia Breeze2 systems.
Too-high readings may result in diabetes patients giving themselves too much insulin. Insulin overdoses are dangerous and could be deadly. So far, the FDA has reported no injuries or deaths.
Bayer issued the recall when routine quality monitoring showed that certain lots of the test strips give readings 5% to 17% too high -- outside product specifications. The problem, Bayer says, was with new manufacturing equipment designed for the new Contour TS strips. According to Bayer, the problem has been corrected.
Bayer asks consumers to check the lot number on the bottles of Contour TS strips. Lot numbers appear on the bottom of the box and on the side of the bottle containing the strips.
The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). Only bottles of test strips with the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence are affected.
Bottles with a lot number including 7J through 7M after WK are not affected and need not be returned.
Consumers who purchased the recalled strips should call Bayer customer service (in the U.S., 1-800-348-8100) to return any affected bottle of strips and to get a replacement.
The recalled strips have been distributed in the U.S., France, Turkey, Austria, Korea, India, and Mexico.