The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor sensors manufactured by Abbott Diabetes Care. This alert serves as a precautionary measure to inform healthcare providers, distributors, and patients about inaccuracies in low glucose readings reported by the FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring (CGM) systems, which could lead to incorrect diabetes management decisions.
Affected Products and Who Should Care
The identified issue concerns the FreeStyle Libre 3 Sensor (Model Numbers: 72081-01 and 72080-01) and the FreeStyle Libre 3 Plus Sensor (Model Numbers: 78768-01 and 78769-01). These devices are used for real-time glucose monitoring in individuals aged four and older who manage diabetes. Abbott has confirmed that no other products in their Libre line are impacted, including the FreeStyle Libre 14 Day, FreeStyle Libre 2, and FreeStyle Libre Pro systems.
Healthcare providers, distributors, and individuals using the FreeStyle Libre 3 and Libre 3 Plus sensors should immediately verify whether their devices are affected by locating the sensor serial numbers. Customers can check their sensors on the designated website.
How to Check Serial Numbers
Patients using the FreeStyle Libre 3 or FreeStyle Libre 3 Plus CGM systems can find the sensor serial number through various methods:
- Using the App: Navigate to the “About” screen in the FreeStyle Libre 3 app or access “Profile > About” in the Libre app to view serial numbers under “Last 3 Sensors.”
- Using the Reader: Access the “System Info” menu under “System Status” in the FreeStyle Libre 3 reader for the serial number details.
- On the Sensor Packaging: The serial number can also be found on the label on the bottom of the sensor applicator or carton.
For sensors used alongside connected insulin delivery devices, users should consult the delivery device’s user manual for further steps.
Risks of Incorrect Readings
Abbott Diabetes Care has reported that certain affected sensors may provide inaccurate low glucose readings. These inaccuracies could result in improper treatment decisions, such as excessive carbohydrate intake or delayed insulin administration. If unaddressed over time, such actions may have serious health repercussions, including injury or even death in severe circumstances. As of November 14, 2025, there have been 736 serious injuries and seven deaths linked to this problem.
The FDA advises that individuals use a reliable blood glucose meter, or the built-in blood glucose meter within the FreeStyle Libre 3 Reader, to verify treatment decisions when sensor values differ from symptoms or expected patterns.
Manufacturer-Recommended Actions
Abbott has issued detailed instructions for affected customers to mitigate these risks:
- Individuals should discontinue the use of the affected sensors immediately and dispose of them as advised.
- Patients and healthcare professionals are directed to confirm if their sensors are impacted by checking serial numbers on the official FreeStyle Check website.
- Users of impacted sensors may request replacement units at no cost by following the instructions provided on the same website.
- Health care providers are urged to inform patients of this issue and guide them through the necessary steps for sensor verification and replacement.
Distributors and wholesalers are advised to inspect their inventory for affected lots, remove such products from stock, and return them through normal channels.
Importance of Device Identifiers
The Unique Device Identifier (UDI) system plays a vital role in the traceability of medical devices. For the sensors in question, the identified UDIs are:
- FreeStyle Libre 3 Sensor: 00357599818005, 00357599819002
- FreeStyle Libre 3 Plus Sensor: 00357599844011, 00357599843014
The UDI system allows for streamlined incident reporting, device tracking, and analysis of adverse events, enabling prompt corrective action where necessary.
How to Report Adverse Events
Health professionals and consumers are encouraged to report any adverse reactions or quality issues linked to the affected sensors. Reports can be submitted via MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program. Visit the MedWatch website for more details.
Alternatively, customers can direct their concerns to Abbott Diabetes Care by contacting the support hotline at 1-833-815-4273 or through their customer service website.
Conclusion
The FDA’s Early Alert is a serious call to action for patients, healthcare providers, and distributors. Abbott Diabetes Care has provided resources for verifying affected sensors and emphasized the importance of discontinuing use of potentially faulty devices. For those impacted, immediate steps should be taken to address the risks and secure replacement sensors.
Disclaimer
This is an informational article intended for healthcare professionals. It does not constitute legal advice and must not be relied upon as such.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care