Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters
MedSun: Newsletter #85, June 2013

FDA MedWatch Safety Alert

At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter may display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur, they are a serious health risk that requires immediate medical attention.

Additional Information:

Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters. FDA MedWatch Safety Alert. May 20, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353136.htm


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