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Potential 50,000 Blood Glucose Meters Recalled Due to Inaccurate Low Readings and Risk of Serious Injury or Death


At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle lnsulinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. This inaccurately low reading could delay emergency treatment leading to serious injury or death.

 

The company has determined that, for example, at a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL - 1024 mg/dL = 42 mg/dL). Normal fasting blood sugar levels range from 70-100 and high levels range from 180-500. Levels over 1000 would be rare but life threatening.

 

Abbott estimates that there are approximately 50,000 active FreeStyle lnsulinx Meter users in the United States. Customers who are using the FreeStyle lnsulinx Meter can access a software update to resolve the issue. The software update will allow customers to maintain settings and historical data on their meter. Alternatively, customers can contact Abbott Diabetes Care Customer Service to expedite return and replacement of their FreeStyle lnsulinx meter at no charge. Replacements are available, and Abbott will send meters to customers immediately upon request.

 

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