Abbott FreeStyle Libre 3 CGM Recall Designated Class I

Recently designated as Class I by FDA, Abbott Laboratories is recalling certain FreeStyle Libre 3 sensors after it was found that there was a risk for inaccurate high glucose readings. The FreeStyle Libre 3 continuous glucose monitoring (CGM) system helps individuals manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be continuously adjusted to match patient need.

Abbott’s diabetes care unit launched the CGM recall after finding that a small number of the sensors may provide inaccurate high glucose readings, which could cause significant health risks for diabetics if left undetected. Use of the affected CGMs could cause hypoglycemia, which could result in central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death. Currently, there have been two reported injuries, and no deaths connected to the issue.

On July 24, Abbott sent all affected customers an Urgent Medical Device Recall Notice recommending they stop using the device and dispose of any affected product. Patients and distributors can request a replacement of any affected sensors through the company. To request a replacement, customers must have their sensor serial number, which can be found on the package carton, in the FreeStyle Libre 3 app, and in the reader.

It is also recommended to conduct a fingerstick test using any blood glucose meter if patient symptoms do not match the CGM reading. The FreeStyle Libre 3 reader includes a built-in blood glucose meter that is not affected by the recall and can be used to check glucose at any time.