From:
Sukie Crandall
Date: 2007-12-26 21:47:50 UTC
Subject: [ferrethealth] Bayer glucose test strips recalled
To: ferrethealth@yahoogroups.com, ferret-l@LISTSERV.FERRETMAILINGLIST.ORG
They are giving numbers as much as 17% higher than they should even=20
for humans. (For ferrets the human testing devices should best be=20
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=20
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=20
> withdrawals from the firms involved as a service to consumers, the=20
> media, and other interested parties. FDA does not endorse either the=20
> 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=20
> Diabetes Care has initiated a voluntary market recall of test strips=20
> (sensors) used exclusively with the Contour TS Blood Glucose Meter.=20
> In the course of its routine quality control monitoring processes=20
> the Company identified a manufacturing issue with test strips from=20
> specific lots that could result in blood glucose readings with a=20
> positive bias that is outside of our product specifications. Test=20
> results may demonstrate results 5 -17% higher.
>
> This issue is unrelated in any way to the Contour TS meter itself=20
> and pertains only to certain test strips used with the meter.=20
> Additionally, this issue has no impact on the performance of strips=20
> used with other Bayer meters including Ascensia Contour and Ascensia=20
> Breeze2 systems.
>
> The affected Contour TS strips were produced during the initial=20
> manufacturing process on new manufacturing equipment designed for=20
> the new Contour TS strips. The root cause of the problem has been=20
> identified, and corrective actions implemented including additional=20
> quality control measures to prevent recurrence. The quality of our=20
> products and the results our customers receive are very important to=20
> Bayer and, as such, we are notifying regulatory authorities,=20
> healthcare professionals and customers in the countries where=20
> Contour TS is marketed =96 France, Austria, Turkey, Korea, Mexico and =
> predominantly through mail order channels in the United States.
>
> Healthcare providers, retailers, patients and other customers who=20
> use Contour TS are advised to check the lot number on the bottles of=20
> Contour TS strips and to contact Bayer Diabetes Care for information=20
> regarding return and replacement of strips. The lot numbers can be=20
> found on the bottom of the box and on the side of the bottle=20
> containing the strips. The affected lots begin with WK followed by=20
> the characters 7D, 7E, 7F or 7G and then followed by a series of=20
> other numbers and letters (for example WK7ED3E52C). Only bottles of=20
> test strips with the characters 7D, 7E, 7F, or 7G in the third and=20
> fourth position in the sequence are affected. Bottles with a lot=20
> number including 7J through 7M after WK are not affected and need=20
> not be returned. Additional information can be found at www.bayerdiabet=
es.com
> . Please call your Bayer customer service phone number (in the U.S.,=20
> call 1-800-348-8100) to return any affected bottle of strips and to=20
> get a replacement.
>
> Affected Product Code Numbers by Country... [See the release to get=20
> 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
Yahoo! Groups Links
<*> To visit your group on the web, go to:
http://groups.yahoo.com/group/ferrethealth/
<*> Your email settings:
Individual Email | Traditional
<*> To change settings online go to:
http://groups.yahoo.com/group/ferrethealth/join
(Yahoo! ID required)
<*> To change settings via email:
mailto:ferrethealth-digest@yahoogroups.com
mailto:ferrethealth-fullfeatured@yahoogroups.com
<*> To unsubscribe from this group, send an email to:
ferrethealth-unsubscribe@yahoogroups.com
<*> Your use of Yahoo! Groups is subject to:
http://docs.yahoo.com/info/terms/