Class 1 Recall: Abbott Diabetes Care, FreeStyle InsuLinx Blood Glucose Meters

Reason for Recall:

Incorrect Test Results at Extremely High Blood Glucose Levels.

At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.

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).

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. If the FreeStyle InsuLinx Blood Glucose Meter displays an inaccurate low result, there may be a delay in identification and treatment of severe high blood glucose levels (hyperglycemia), or inappropriate treatment may be administered to the patient. This could lead to serious injury or death.

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