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Abbott announced a voluntary recall of FreeStyle InsuLinx blood glucose meters in the U.S.
At extremely high blood glucose levels of >1,024mg/dL, the FreeStyle InsuLinx meter displays and stores an incorrect test result that is 1,024mg/dL below the actual measured result. For example, at a blood glucose value of 1,066mg/dL, the meter will display and store a value of 42mg/dL (1,066mg/dL – 1,024mg/dL = 42mg/dL).
Although blood glucose levels at >1,024mg/dL are very rare, they are a serious health risk when they occur. With the meter displaying an inaccurate low result at a blood glucose level above >1,024mg/dL, there may be a delay in the identification and treatment of severe hyperglycemia, or an incorrect treatment may be given.
Customers who are using the FreeStyle InsuLinx meter are to either access a software update to resolve the issue or contact customer service at (866) 723-2697 to receive a replacement of their meter at no charge. No other Abbott blood glucose meters are affected by this issue.
For more information call (866) 723-2697 or visit www.freestyleinsulinx.com/swupdate/indexus.html.
