Freestyle Blood Glucose Monitoring System and Freestyle Mini Blood… — recall 51244
Health Canada — Medical Devices · Canada · 2014-03-25 · Type II
As described by Health Canada — Medical Devices: Freestyle Blood Glucose Monitoring System and Freestyle Mini Blood Glucose Monitor (2014-02-21)
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Archived by the issuing authority — kept for reference
Reported risk: Abbott has identified through internal testing and investigation that all non-applied voltage legacy meters (here after referred to as 0 mV meters) have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Freestyle test strip lot within expiry. This issue only occurs when Freestyle and Freestyle Lite strips are used with the Freestyle blood glucose meter, the Freestyle mini blood glucose meter, and the Freestyle blood glucose meter built into the Omnipod Insulin Management system (or 0 mV meters).
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