A unit of Bayer AG recalled diabetes test strips used with its Contour TS Blood Glucose Meter because they may result in 5 to 17 percent higher blood glucose readings, the U.S. Food and Drug Administration said on Wednesday.
The test strips are used by diabetic patients to monitor their daily blood sugar levels.
Bayer Diabetes Care said the recalled test strips were produced on new manufacturing equipment and that it has fixed the problem.
Some 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.
The recalled strips have lot numbers that begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters. Bottles with 7J through 7M in the third and fourth position in the sequence are not included in the recall. These lot numbers are printed on the bottom of the box and the side of the bottle.
Contour TS strips are sold predominantly through mail order in the United States and are also marketed in France, Austria, Turkey, Korea, India and Mexico, according to Bayer.
The company said the problem was unrelated 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.
Details are available by phone at 800-348-8100 or at Bayer Diabetes on the Web.