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Freestyle InsuLinx meter recalled due to inaccurate readings
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FreeStyle InsuLinx blood glucose meters have been recalled in the United States, according to a manufacturer press release. The manufacturer has notified the FDA, relevant health care authorities and agencies in other countries potentially affected by the recall.
The meters made by Abbott Diabetes Care are being recalled due to an inaccurately high blood glucose reading of 1,024 mg/dL and above. According to the release, the FreeStyle InsuLinx meter will display and store in memory an incorrect test result that is 1,024 mg/dL below the measured result.
Although unlikely, a glucose level of 1,024 mg/dL would require prompt immediate medical attention, with potentially serious health risk or fatality.
“To date, there has been one reported patient incident in the United States that may be related to this specific issue. The patient sought medical treatment, was diagnosed with hyperglycemia, treated and released. It has not been determined that the FreeStyle InsuLinx Meter was the cause,” the manufacturer press release said.
According to the release, no adverse events have been reported outside the United States. The meter is available in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and the United Kingdom.
Health care providers are advised to immediately discontinue dispensing these blood glucose kits to patients. For information on product return and replacement, physicians are advised to call Abbott Diabetes Care customer service at 1-866-723-2697.
Additional information about this recall can be found at www.abbottdiabetescare.com, according to the release.