The Food and Drug Administration issued an “early alert” concerning FreeStyle Libre 3 and FreeStyle Libre Plus sensors used by people who have diabetes.
The agency said Abbott Diabetes Care has sent a letter to distributors, health care providers and customers saying that some sensors need to be removed from where they are sold or used.
The company said that some sensors are giving incorrect low glucose readings. If not detected correctly, low glucose readings may lead to wrong treatments, such as eating too many carbohydrates or skipping or delaying insulin doses.
There have been 736 serious injuries and seven deaths as of Nov. 14 related to the problem, the FDA said.
The devices are supposed to provide continuous, real-time glucose monitoring. They also detect trends and patterns.
The following devices are part of the alert:
- FreeStyle Libre 3 Sensor with model numbers 72081-01 or 72080-01. They have unique device identifiers of 00357599818005 or 00357599819002
- FreeStyle Libre 3 Plus Sensor with model numbers 78768-01 or 78769-01 with unique device identifiers of 00357599844011 or 00357599843014.
Click here to see all of the lots that are part of the alert.
The FDA said that the readers and mobile apps are not affected, nor are other FreeStyle Libre items.
If you have a sensor that is part of the alert, you are told to discontinue use immediately and dispose of it. You can request a replacement sensor if yours is affected by visiting the FreeStyle Check website and entering your serial number.
The FDA also advises that diabetic patients use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 Reader when their sensor does not match their symptoms or expectations.
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