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US Action Follows Stop-Ship That Began in June
Tarrytown, NY-Bayer HealthCare confirmed today that it is recalling all 10- and 25- count Contour strips and 10-count Contour TS test strips from US retail stocks, retail distribution channels and offices of US healthcare professionals. The FDA is aware of the voluntary action.
Fifty (50)-count vials of Contour test strips are not affected, nor are strips used with Bayer's BreezeTM2 blood glucose meters.
Bayer says it has taken the action as a precautionary measure and not as the result any adverse events reported to it. The company says it is acting to address a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of FDA performance specifications. The strips can produce a low-bias reading during blood glucose testing. In the FDA's view, this deviation from specifications constituted a technical violation that required a field corrective action under US regulations.
The U.S. recall follows Bayer's decision in late June to stop new shipments of products containing the small-count vials of these small-vial test strips world-wide. With no new shipments of small-count vials coming into the market since that time, Bayer believes that remaining unused quantities of potentially affected product in the market are very small.
While it resolves the small-count vial issue, Bayer has increased its stocks of 50-count vials and is using these to fulfill new orders to ensure uninterrupted consumer access to unaffected strips.
A Bayer spokeswomen told Diabetes Health that testing and analysis by Bayer show that patients acting on results produced by an affected strip from an affected vial "would not experience any clinically adverse event as the degree of bias in the results fall within Zones A and B on the Consensus error grid. In this medically-accepted reference tool, results falling into Zone A denote ‘no effect on clinical action' and results falling into Zone B denote ‘altered clinical action but little or no effect on clinical outcome.'" She says that the vast majority-95 percent+-of test strips sold and used in the United States are in 50-count vials and are, therefore, unaffected by this issue.
She adds that Bayer is confident that although some patients may receive inaccurately low test results and temporarily fail to completely treat elevated blood glucose levels, such low test results have only an extremely small and unlikely potential to cause adverse health consequences. "In our view, the potentially larger risk would occur should patients misunderstand the issue, mistakenly assume that every strip in their possession is affected, and delay regular blood glucose testing or fail to test at all."
1 comment - Aug 27, 2011
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