TARRYTOWN, N.Y. Bayer Diabetes Care last week initiated a voluntary market recall of test strips used exclusively with the Contour TS Blood Glucose Meter.
In the course of its routine quality control monitoring processes the Bayer identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of product specifications. Test results may demonstrate results between 5 percent and 17 percent higher, the company reported.
This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter, Bayer clarified. Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems, the company said.
Healthcare providers, retailers, patients and other customers who use Contour TS are advised 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. 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.
In the U.S., the affected product code numbers include: 1802, 1802N, 1820, 1823, 1825 and 9578.