A Medical Device Daily
Test strips for a Bayer (Leverkusen, Germany) blood glucose meter may be providing readings that are too high, and they are being recalled, the FDA said Wednesday.
A unit of Bayer recently recalled diabetes test strips used with its Contour TS blood glucose meter because they may result in 5% to 17% higher blood glucose readings. Diabetic patients use the test strips to monitor their daily blood sugar levels.
Bayer Diabetes Care (Tarrytown, New York) said the recalled test strips were produced on new manufacturing equipment and that it has fixed the problem. The problem was identified during routine quality control monitoring, the company said.
About 53 production lots were affected by the recall, totaling 230,000 bottles of strips, a Bayer spokeswoman said. Each bottle typically contains 25 to 50 strips.
Contour TS strips are sold predominantly through mail order in the U.S. and are also marketed in France, Austria, Turkey, Korea, India and Mexico, according to Bayer.
Too-high readings may result in insulin overdoses, which are dangerous and could be deadly.
The company said the problem was “unrelated in any way” to the Contour TS meter and pertained only to certain test strips used with the meter. The recall does not affect strips used with other Bayer meters, Bayer said.
The lot numbers are placed on the bottom of the box and on the side of the bottle containing the strips. According to the company, 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. Only bottles of test strips with a lot number including 7J through 7M are not affected, Bayer said.