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ALAMEDA, Calif. — Abbott Diabetes Care earlier this week initiated a voluntary recall of its FreeStyle lnsulinx Blood Glucose Meters in the United States.
"Our first priority is to safeguard the health and safety of patients," stated Heather Mason, SVP Diabetes Care, Abbott. "We are committed to ensuring that our customers are able to continue to test their blood glucose with confidence, and we initiated this voluntary recall to ensure our products continue to meet the highest standards of quality and safety."
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.
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, the company noted.
The company is notifying all registered users, healthcare professionals, pharmacies and distributors where the FreeStyle lnsulinx Meter is sold. Abbott estimates that there are approximately 50,000 active FreeStyle lnsulinx Meter users in the United States.
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