The Office of Developmental Programs (ODP) is sharing this important announcement from the U. S. Food and Drug Administration (FDA).
The FDA is aware that Abbott Diabetes Care has sent all affected customers, distributors, and health care providers a letter regarding an issue with certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors providing incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.
As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue
Affected Product
- FreeStyle Libre 3 Sensor
- Model Numbers: 72081-01, 72080-01
- Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
- FreeStyle Libre 3 Plus Sensor
- Model Numbers: 78768-01, 78769-01
- Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
What to Do
Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s).
On November 24, 2025, Abbott Diabetes Care sent all affected customers a letter recommending the following actions:
- For Patients:
- Determine if your current or unused sensor(s) are affected by visiting www.freestylecheck.comExternal Link Disclaimer and selecting “CONFIRM SENSOR SERIAL NUMBER.” You will need to locate your sensor serial number to determine if your sensor is affected.
- If you are wearing a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor, you can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.)
- Please see images below for visual aids on where to locate the sensor serial numbers.
- If you are currently wearing or have a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on www.FreeStyleCheck.comExternal Link Disclaimer or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s).
- You can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.comExternal Link Disclaimer. Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost.
- Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don’t match your symptoms or expectations.
For additional information and instructions on how to locate the Sensor’s Serial Number click on this link.
