April 11, 2023

FDA: Class I recall of Abbott’s glucose monitoring systems

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on April 6, identified the recall by Abbott of its FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems as Class I, the most serious.

The recall was initiated because the systems’ reader devices, which use rechargeable lithium-ion batteries, may get extremely hot, spark, or catch on fire if not properly stored, charged, or used with the USB cable and power adapter provided by Abbott.

The company has received reports of 206 incidents, including at least 7 fires, 1 injury, and no deaths involving this issue.

Distribution dates were November 2017 to February 2023.

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