Subject: Test Strip Recall for CONTOUR TS (Dec. 21)

                       

Test Strip Recall for CONTOUR TS (Dec. 21) <http://www.fda.gov/oc/po/firmrecalls/bayer12_07.html> Wed, 26 Dec 2007 09:02:00 -0600          

           

Bayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter.      



Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Test Strip Recall for CONTOUR TS
Contact:
Bayer Customer Service
1-800-348-8100

FOR IMMEDIATE RELEASE -- U.S. -- 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 - France, Austria, Turkey, Korea, Mexico and predominantly through mail order channels in the United States.

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 lot numbers can be found on the bottom of the box and on the side of the bottle containing the 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.  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. Please call your Bayer customer service phone number (in the U.S., call 1-800-348-8100) to return any affected bottle of strips and to get a replacement.

Affected Product Code Numbers by Country

     Country
    Product
    Product Code
   
     U.S.
    Meter kit with 10 strips
    1802
   
     U.S.
    Meter kit with 10 strips
    1802N
   
     U.S.
    Bottle of 50 strips
    1820
   
     U.S.
    Bottle of 50 strips
    1823
   
     U.S.
    Bottle of 25 strips
    1825
   
     U.S.
    Bottle of 10 strips
    9578
   
     France/Turkey/Austria
    Meter kit with 10 strips
    1803
   
     France
    Meter kit with 10 strips
    1803V
   
     Austria
    Bottle of 50 strips
    1826
   
     France
    Bottle of 50 strips
    1826V
   
     Austria/Turkey
    Bottle of 50 strips
    1827
   
     Austria/Turkey
    Bottle of 100 strips
    1828
   
     Austria/Turkey
    Bottle of 25 strips
    1829
   
     Korea
    Meter kit with 10 strips
    1810
   
     Korea
    Bottle of 50 strips
    1835
   
     Korea
    Bottle of 100 strips
    1836
   
     India/Korea/Mexico
    Meter kit with 10 strips
    1811
   
     India
    Bottle of 25 strips
    1832
   
     India
    Bottle of 50 strips
    1833
   
     India
    Bottle of 10 strips
    1837
   
     Mexico
    Meter kit with 10 strips
    1813
   
     Mexico
    Bottle of 50 strips
    1823
   
     Mexico
    Bottle of 25 strips
    1825