April 17, 2013
Abbott Recalls FreeStyle lnsulinx® Blood Glucose Meters in the United States
The Missouri Department of Health and Senior Services received information regarding a recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States.
The company has determined that 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. 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). No other Abbott blood glucose meters are impacted by this issue.
Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above do occur, they are a serious health risk and require immediate medical attention. As the FreeStyle lnsulinx Meter can display an inaccurate low result at a blood glucose level above 1024 mg/dL, there may be a delay in the identification and treatment of severe hyperglycemia, or incorrect treatment may be given. This could lead to serious injury or death.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm348391.htm?source=govdelivery.