Abbott Announces Major Correction Program for FreeStyle Libre 3 Continuous Glucose Monitoring Systems

Abbott Laboratories has launched a comprehensive correction initiative across the United States for its FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring devices. The move comes after quality assessment procedures detected that certain glucose sensors in circulation may be producing inaccurate low blood sugar readings.

The Issue and Response

Through rigorous internal quality testing, Abbott pinpointed the root cause: a specific defect originating from one of its manufacturing facilities. The company has confirmed that this problem has been addressed and resolved at the source. Production of both FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors continues uninterrupted to fulfill replacement orders and meet ongoing customer demand, with Abbott stating it anticipates no substantial disruptions to supply chains.

Scale of Impact

The correction program encompasses approximately 3 million sensors currently distributed in the U.S. market. However, Abbott notes that roughly 50% of these units have either reached their expiration dates or have already been deployed by users, effectively narrowing the scope of active affected devices. On a global scale, the company has documented 736 reports of serious adverse events, with seven cases potentially linked to the sensor malfunction.

Consumer Protection and Replacement Process

Abbott has established a dedicated resource center at www.FreeStyleCheck.com where users can verify whether their specific sensor model falls within the affected batch. For any impacted devices identified, Abbott guarantees replacement at zero cost to consumers. The website provides comprehensive instructions for device verification and straightforward procedures for requesting replacement units.

This proactive correction underscores Abbott’s commitment to maintaining product safety and consumer confidence in its glucose monitoring technology.