NORTH CHICAGO (dpa-AFX) - Diversified healthcare company Abbott Laboratories (ABT) announced the initiation of a voluntary recall of FreeStyle InsuLinx 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 InsuLinx Meter would display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. No other Abbott blood glucose meters are impacted by this issue.
Blood glucose levels at 1024 mg/dL and above are very rare. Still, 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 InsuLinx 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, which may lead to serious injury or death, the company added.
Abbott is notifying all registered users, healthcare professionals, pharmacies and distributors, where the FreeStyle InsuLinx Meter is sold. Abbott projects that there are about 50,000 active FreeStyle InsuLinx Meter users in the U.S. On identifying the problem, the healthcare giant promptly developed and implemented an update to the meter.
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