Abbott Receives FDA Warning Letter over Freestyle Libre CGMs

Abbott receives FDA warning letter over Freestyle Libre CGMs

Abbott needs to conduct more performance testing to ensure its FreeStyle Libre devices are accurate, FDA inspectors found.

Abbott receives FDA warning letter related to FreeStyle Libre CGMs

The sensor for the next-generation FreeStyle Libre 3 CGM is the same size as two U.S. pennies stacked together. [Image courtesy of Abbott]Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre CGM production. The FDA issued the letter on Jan. 23 and made it public today, Feb. 3. It relates to an inspection of Abbott’s Alameda, California, facility from Oct. 14, 2025, through Oct…

Abbott (ABT) stock slips on FDA warning letter over FreeStyle Libre testing; dates to watch

New York, Feb 3, 2026, 15:42 ET — Regular session. Shares of Abbott Laboratories dipped 0.6% to $108.77 Tuesday afternoon after the U.S. Food and Drug Administration issued a warning letter to Abbott Diabetes Care. The letter, dated Jan. 23, criticized the company’s process for verifying the accuracy of its FreeStyle Libre continuous glucose monitors (CGMs). Specifically, the FDA said Abbott failed to ensure key accuracy specs were passed to thi…