Abbott Recalls FreeStyle Libre 3 Sensors

Abbott Diabetes Care is recalling (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes. The sensors are used in Abbott’s FreeStyle Libre 3 Continuous Glucose Monitoring System, which is intended to provide continuous monitoring of glucose levels. “It helps people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed,” FDA says.

“The use of affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia) which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death,” a recall notice says. To date, it says there have been two reported injuries and no reports of death.

The notice says the recall does not apply to the FreeStyle Libre 3 reader or app.