FreeStyle InsuLinx blood glucose meters for people with diabetes are being recalled in the United States due to safety concerns.
In a press release, manufacturer Abbott said it has issued a voluntary recall of the diabetes care product in the US after determining that at extremely high blood glucose levels of 1024 mg/dL (56.9 mmol/L) and above, it displays and stores in memory an incorrect test result that is 1024 mg/dL below the measured result.
This fault could cause a delay in the detection and treatment of severe hyperglycemia, or lead to incorrect treatment, increasing the risk of serious injury or death.
Abbott has notified all registered users, healthcare professionals, pharmacies and distributors of the problem, as well as the US Food and Drug Administration and all relevant healthcare authorities in the other countries where the FreeStyle InsuLinx meter is sold.
Users of the blood glucose meter is America are being advised to either contact Abbott Diabetes Care Customer Service to return their product and receive a free replacement, or update the meter software to resolve the issue at
Heather Maso, senior vice president of Abbott Diabetes Care, said: “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. We regret any inconvenience this action may cause.”
The global healthcare giant said to date, there has been one reported patient incident in United States that may be related to this specific issue, but stressed that no adverse events have been reported outside the US.

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