FreeStyle InsuLinx Blood Glucose Monitoring System (Abbott) is recalled in the USA

The Freestyle Insulinx Blood Glucose Monitoring System has been recalled by Abbott Diabetes Care in the United States. The FDA has assigned its most-serious Class I label to the recall warning that the devices' malfunction could lead to serious injury or death.

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.