Medical Device Correction for FreeStyle Libre 3 Sensors

On July 24, 2024, Abbott Diabetes Care, Inc. issued a medical device correction for FreeStyle Libre 3 Sensors because they can give an incorrectly high glucose reading, posing a potential health risk for people with diabetes. On Aug. 27, 2024, the FDA upgraded the device correction to a Class I recall. Affected patients should stop using the sensors immediately and request a replacement on the manufacturer’s website or contact the dispensing pharmacy. Since patients may not receive accurate readings from the sensor, there is a potential risk for calculating higher insulin doses than needed or delaying recognition for low blood glucose levels (hypoglycemia) that could lead to significant adverse health effects or death. To read more about the recall, see here.