Abbott Issues Correction for Freestyle Libre 3 Sensors After Faulty Low Readings

Abbott has announced a medical device correction affecting about 3 million Freestyle Libre 3 and Libre 3 Plus sensors in the U.S., following reports that some devices may generate falsely low glucose readings. The company has linked the issue to one production line and has documented 736 severe adverse events and seven deaths globally. In the U.S., 57 serious events were reported, with no fatalities.

Incorrect low readings could prompt users to delay insulin dosing or consume unnecessary carbohydrates, potentially leading to harmful outcomes. Abbott says the problem has been resolved and will replace all potentially affected sensors at no cost.

The FDA cleared the Libre 3 in 2022 and the Libre 3 Plus in 2023. Approximately half of the impacted sensors are thought to already be expired or used, and the FDA has yet to list the correction in its recall database. Abbott expects no supply disruptions. 

02-12-2025