German drugmaker Bayer AG recalled diabetes test strips used with its Contour TS Blood Glucose Meter because they do not provide correct blood glucose readings.
Bayer Diabetes Care, a unit of Bayer AG, announced Friday, Dec. 21, that it would voluntarily recall test strips used exclusively with the Contour TS Blood Glucose Meter after a routine quality control revealed the certain lots of the product presented a problem.
Bayer said the products may overstate how much sugar is in the blood by 5 to 17 percent.
A statement from the company emphasized that the problem with some of the test strips “is unrelated in any way to the Contour TS meter itself and pertains only to certain test strips used with the meter.”
“Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems,” the statement added.
Bayer said the test strips that do not function properly owe their inefficiency to a defect in manufacturing. Certain lots of the product are to be recalled in the U.S., France, Turkey, Austria, Korea, India and Mexico.
A notice has also been posted on the U.S. Food and Drug Administration's website, detailing the affected lots’ product code and numbers.
A Bayer spokeswoman said fifty-three production lots were affected by the recall, totaling 230,000 bottles of strips.
Healthcare providers, retailers, patients and other customers who use Contour TS are advised to contact Bayer Diabetes Care for information regarding return and replacement of strips.
The affected lots begin with WK followed by 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters. One example is WK7ED3E52C, the company said.
For more information, visit http://www.bayerdiabetes.com/Contour_TS_RECALL_CHART.pdf
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