The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Meter will display and store incorrect test result in the memory , 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.
Abbott has notified the US FDA and all relevant healthcare authorities in the other countries. Abbott is working with the individual regulatory agencies around the world where the affected products have been sold.
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