Counter TS Test Strip Recall Issued After Bayer Diabetes Care Reports Manufacturing IssueDec 26, 2007 | Parker Waichman LLP
Bayer Diabetes Care has initiated a voluntary market recall of test strips—or sensors—that are used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Bayer Diabetes Care identified a manufacturing issue with defective devices from specific lots. The defect could result in blood glucose readings with a positive bias that is outside of their product specifications and test results may demonstrate results 5-17% higher. This problem is with the strips only—and only with specific test strips used with the Contour TS Blood Glucose Meter—and is unrelated in any way to the Contour TS meter itself. Also, the Contour TS test strip recall has no impact on the performance of strips used with other Bayer meters including the Ascensia Contour and Ascensia Breeze2 systems.
The affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips. The cause of the problem has been identified and corrective actions have already been implemented, including incorporating additional quality control measures to prevent recurrence. “The quality of our products and the results our customers receive are very important to Bayer and, as such, we are notifying regulatory authorities, healthcare professionals and customers in the countries where Contour TS is marketed—France, Austria, Turkey, Korea, Mexico, and predominantly through mail order channels in the United States,” said Bayer in a prepared statement.
Healthcare providers, retailers, patients, and other customers who use the 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 lot numbers can be found on the bottom of the box and on the side of the bottle containing the strips and 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. Bottles with a lot number including 7J through 7M after WK are not affected and need not be returned. Additional information can be found at www.bayerdiabetes.com. Customers are urgerd to contact Bayer Customer Service (in the U.S., call 1-800-348-8100) to return any affected bottle of strips and to receive replacement strips.
When people with diabetes can control their blood sugar (glucose), they are more likely to stay healthy. People with diabetes use two kinds of management devices: Glucose meters and other diabetes management tests. Glucose meters—which use glucose test strips—help enable people with diabetes to check their blood sugar at home, school, work, and play. As a general rule, the American Diabetes Association (ADA) recommends that most patients with Type 1 diabetes test their glucose three or more times per day. Pregnant women taking insulin for gestational diabetes should test two times per day. ADA does not specify how often people with type 2 diabetes should test their glucose, but testing often helps control the disease.