FDA Issues Early Alert on Abbott Libre 3 Sensors Over False Lows Linked to 7 Deaths

Overview

• Roughly 3 million FreeStyle Libre 3 and Libre 3 Plus sensors are affected, according to Abbott and the FDA.
• Abbott has reported 736 severe adverse events worldwide, including 57 in the U.S., and seven deaths reported outside the U.S.
• Users are urged to check serial numbers at www.FreeStyleCheck.com, stop using impacted sensors, and request free replacements.
• The FDA’s notice is an Early Alert signaling a potentially high-risk issue rather than a formal recall.
• Abbott says the problem was limited to one production line, has been resolved, and replacement and new orders are continuing without expected supply disruptions.