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Old 04-16-2008, 10:47 AM
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Default Re: Animal Validated Meters???

http://www.fda.gov/medwatch/safety/2...rTS_recall.htm

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, India 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.

So it only had to do with that particular model of Contour--TS and that is or was available here through mail order channels only.

Here it is again on the FDA Enforcement Report for March 19, 2008--when the recall is incomplete, FDA will, after a period of time, re-list the product in Enforcement Reports.

http://www.fda.gov/bbs/topics/ENFORC.../ENF01048.html

PRODUCT
a) Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips
enclosed; Products 1802 and 1802N (U.S.)
, 1810 (Korea), 1811 (India, Korea and
Mexico) and 1825 (Mexico), Recall # Z-0931-2008;
b) Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100
strips; U.S. Product codes 1820, 1823, 1825 and 9578;
1835 and 1836 (Korea);
1832, 1833 and 1837 (India); 1823 and 1825 (Mexico), Recall # Z-0932-2008

CODE
a) Test strip lots: WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C,
WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A,
WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F,
WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C,
WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C,
WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A,
WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B;
b) Test strip lots: WK7DD3E31A, WK7DD3E31B, WK7DD3E31D, WK7DD3E51C,
WK7DD3E51D, WK7ED3E02A, WK7ED3E04A, WK7ED3E51B, WK7ED3E52A,
WK7ED3E52C, WK7ED3E52D, WK7ED3E52E, WK7ED3E53C, WK7ED3E53F,
WK7FD3E01C, WK7FD3E01D, WK7FD3E01E, WK7FD3E04A, WK7FD3E31C,
WK7FD3E31D, WK7FD3E31E, WK7FD3E31F, WK7FD3E31H, WK7FD3E32C,
WK7FD3E34A, WK7FD3E34B, WK7FD3E51A, WK7FD3E51B, WK7GD3E01A,
WK7GD3E02A, WK7GD3E05A, WK7GD3E51A and WK7GD3E51B


RECALLING FIRM/MANUFACTURER
Bayer Healthcare LLC, Mishawaka, IN, by press release and letter on December 21, 2007. Firm initiated recall is ongoing.

REASON
Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

VOLUME OF PRODUCT IN COMMERCE
97,000 bottles of test strips

DISTRIBUTION
Nationwide and Internationally