Abbott Diabetes Care has issued a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus glucose sensors due to reports of malfunctioning readings, prompting a global recall.

Around three million affected sensors were distributed, with the United States and multiple European and other markets including Germany, Austria, Canada, Denmark, Spain, and the United Kingdom among those impacted.

Abbott says the manufacturing issue has been resolved and production is ongoing, and the firm does not anticipate significant supply disruptions for replacements or new orders.

The recall effort has a France-specific dimension, highlighting the global scope and coordination with national authorities.

The recall underscores potential safety risks for patients relying on continuous glucose monitoring from these devices.

Health professionals and consumers are urged to report adverse experiences via the FDA's MedWatch program, with notices sent to distributors, providers, and customers on Nov. 24.

Abbott is executing a correction protocol while ensuring access to replacements and new devices for affected users.

The FDA issued an early safety alert on December 2 after Abbott disclosed the issue on November 24, as regulators evaluate whether a formal recall is warranted.

If readings don’t match symptoms, patients should use a blood glucose meter or the reader’s built-in meter to guide treatment until replacements arrive.

Regulators encourage prompt device verification and adverse event reporting to the FDA's MedWatch program as Abbott works to resolve the issue.

The affected devices are used for continuous glucose monitoring and come from a single production line.

In addition to the US, the recall covers Germany, Austria, Canada, Denmark, Spain, Finland, France, Italy, Luxembourg, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United Kingdom.