Bayer recalls Diabetes Test Strips due to false readings

Bayer Diabetes Care, a unit of Bayer AG, announced yesterday that it has initiated a voluntary market recall of diabetes test strips which might give too-high readings. The diabetes test strips in question are used with the Contour TS Blood Glucose Meter.

Diabetic patients use these strips to monitor their daily blood sugar levels

Bayer issued the recall after it identified a manufacturing glitch with test strips from specific lots in the course of its routine quality control monitoring processes.

The strips are being recalled because they could skew blood glucose readings and produce test results that are 5 percent to 17 percent higher than actual blood glucose levels, the Leverkusen, Germany-based drug maker said.

False readings may result in diabetics giving themselves too much insulin. Overdoses of insulin are dangerous and could be lethal.

The recall affected the strip lots designated with a WK followed by 7D, 7E, 7F, or 7G and then another series of numbers and letters (for example WK7ED3E52C). The strips were packaged in bottles of 10, 25, and 50 and in glucose meter kits with the product code 1802 and 1802N.

The recalled strips were produced on new manufacturing equipment designed for the new Contour TS strips, and had been distributed in the U.S., France, Turkey, Austria, Korea, India, and Mexico through mail order, Bayer said.

The voluntary recall does not affect the Contour TS Blood Glucose Meter, the kit with these strips. Test strips for other Bayer meters, including the Ascensia Contour and the Ascensia Breeze2 systems, are not affected by the recall.

Bayer has urged healthcare providers, retailers, patients and other customers who use Contour TS to check the lot number on the bottles of Contour TS strips and to contact Bayer Diabetes Care for information regarding return and replacement of strips.