The U.S. Food and Drug Administration (FDA) in December issued a safety alert urging people with diabetes to stop using select glucose sensors made by Abbott Laboratories’ (NYSE: ABT) Diabetes Care, after the company linked the devices to seven deaths and hundreds of serious injuries.
Regulators said certain models of the company's FreeStyle Libre 3 sensors may inaccurately show low glucose levels, potentially prompting dangerous treatment decisions.
In a notice published earlier in December, the agency said the affectedFreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors can produce falsely low readings.
Over time, these inaccuracies may lead users to consume unnecessary carbohydrates or postpone insulin doses — actions that can heighten the risk of severe complications, including life-threatening events.
Abbott advised patients to check whether their sensors fall under the recall and to immediately stop using and properly discard any affected devices.
The company outlined corrective steps in a letter sent to its customers on Nov. 24, reiterating the risk of misinterpreting low readings and the potential consequences for people relying on continuous glucose monitoring.
According to the FDA, Abbott also notified distributors, health care providers and customers to remove the impacted sensors from clinical and commercial settings. The alert applies only to specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
Other products in Abbott's glucose monitoring portfolio — including the FreeStyle Libre 14-day, FreeStyle Libre 2, FreeStyle Libre 2 Plus and Libre Pro sensors — are not affected. The agency also stressed that FreeStyle Libre 3 readers and mobile apps remain safe to use.
Abbott reported 736 serious injuries and seven deaths tied to the sensor malfunction as of Nov. 14. The company said undetected inaccuracies may skew long-term treatment decisions and daily glucose management, creating risks of hypoglycemia, hyperglycemia, or other complications.
The FreeStyle Libre 3 and FreeStyle Libre 3 Plus systems are real-time continuous glucose monitoring devices intended for adults and children aged four and older.
Designed to replace traditional finger-stick testing in most scenarios, the systems provide ongoing glucose trends and alerts to help guide both immediate and long-term diabetes management.
These sensors can also connect with compatible digital devices, allowing patients to manually incorporate readings into therapy decisions.