11,500,000+ Bayer Diabetes Care Contour Test Strips Recalled

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11,500,000+ Bayer Diabetes Care Contour Test Strips Recalled

Postby jimithy » Thu Jan 03, 2008 12:19 pm

Bayer Diabetes Care Contour Test Strips (TS)

Audience: Endocrinologists, healthcare professionals, diabetic patients, and pharmacies
[Posted 12/26/2007] Bayer Diabetes Care notified healthcare professionals and consumers of a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. The product was recalled because test strips from specific lots could result in blood glucose readings with a positive bias that could demonstrate 5 - 17% higher test results. This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter. There is no impact on the performance of strips with other Bayer meters.

Healthcare professionals, retailers, patients and other customers who use Contour TS are advised to check the lot number of the test strips in their inventory and contact Bayer Diabetes Care for information regarding the return and replacement of strips. See the manufacturer's press release for specific product lot numbers affected by this recall.

http://www.fda.gov/Medwatch/SAFETY/2007 ... m#diabetes
[quote]Test Strip Recall for CONTOUR TS

December 21, 2007

Bayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Company 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 our product specifications. Test results may demonstrate results 5 -17% higher.

This issue 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 affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips. The root cause of the problem has been identified, and corrective actions implemented including 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
Last edited by jimithy on Thu Nov 05, 2009 10:25 am, edited 1 time in total.
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Postby lindalewis » Tue Aug 18, 2009 8:07 am

Thanks jimithy i read this information :D
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