Glucose test strips recalled

Dec 28, 2007

Too high readings with some contour TS blood glucose meter test strips.

Test strips for a Bayer blood-glucose meter give too-high readings and are being recalled, the FDA announced.

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 Ascension Contour and the Ascension 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 was with new manufacturing equipment designed for the new 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.

Source: webmd.com


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