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Subject:
From:
Sukie Crandall <[log in to unmask]>
Date:
Wed, 26 Dec 2007 16:47:50 -0500
Content-Type:
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They are giving numbers as much as 17% higher than they should even for
humans. (For ferrets the human testing devices should best be taken as
direction indicator not a trustworthy number.)

Some people have written on the lists of using this particular device.

http://www.fda.gov/medwatch/safety/2007/safety07.htm#diabetes

FDA release (with many countries and multiple sizes of packages
involved:

http://www.fda.gov/oc/po/firmrecalls/bayer12_07.html

>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... [See the release to get
>further details.]

Sukie (not a vet)

Recommended ferret health links:
http://pets.groups.yahoo.com/group/ferrethealth/
http://ferrethealth.org/archive/
http://www.afip.org/ferrets/index.html
http://www.miamiferret.org/fhc/
http://www.ferretcongress.org/
http://www.trifl.org/index.shtml
http://homepage.mac.com/sukie/sukiesferretlinks.html

[Posted in FML 5833]


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