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FDA Designates Abbott's Recall of FreeStyle InsuLinx Glucose Meter As Class I

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FDA Designates Abbott's Recall of FreeStyle InsuLinx Glucose Meter As Class I
 The FDA announced Monday that Abbott Diabetes' voluntary recall of the FreeStyle InsuLinx Blood Glucose Meters in the U.S. has been designated as Class I, the most serious of all recalls.

The FDA announced Monday that Abbott Diabetes' voluntary recall of the FreeStyle InsuLinx Blood Glucose Meters in the U.S. has been designated as a Class I Recall, the most serious of medical recalls.

The product provides incorrect results at extremely high blood glucose levels. Abbott initiated the recall on April 15. The devices that are part of the recall were sold between April 18, 2012 and April 1 of this year. 

In its recall notice, Abbott has decribed the problem like this:

We have determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result.

Example: For 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).

The likelihood of experiencing extremely high blood glucose levels 1024 mg/dL and above is rare. However, when they occur, they are a serious health risk and require immediate medical attention. If the FreeStyle InsuLinx meter displays an inaccurate low result, there may be a delay in identification and treatment of severe hyperglycemia (high blood glucose levels). This could lead to serious injury or death.

Consumers who have purchased the over-the-counter device are urged to either install a software update available from Abbott or get a free replacement and return the faulty device at no charge. In the interim period, the current device may be used but both the company and FDA said that if symptoms are inconsistent with the meter readings, patients need to contact their providers immediately. 

-- By Arundhati Parmar, Senior Editor, MD+DI

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