FDA
Warning letter 722046, Abbott Diabetes Care
FDA told Abbott Diabetes Care that FreeStyle Libre continuous glucose monitors, including Libre 3, were being released without finished-device accuracy testing after they were assembled, sterilized, programmed, and packed.
The inspection of the Alameda, California plant ran October 14–23, 2025. The letter says accuracy performance requirements written for the Libre 3 were not transferred into the contract manufacturers’ production specifications. Component-level tests on unassembled sensor tails, FDA writes, do not show that a finished, sterilized unit still meets the iCGM special controls at 21 CFR 862.1355. Management confirmed during the inspection that finished devices are not performance-tested for accuracy at release.
FDA also rejected the firm’s statistical case for lot-release limits: the study used to split manufacturing variability from patient variability, the letter says, cannot actually separate those sources. Proposed sampling plans in Abbott’s written responses lacked the confidence levels and defect-rate assumptions the rule requires.
A warning letter is not a recall. Abbott has a separate, public medical-device correction for certain Libre 3 and Libre 3 Plus sensors that may read low; that announcement is its own file.
fda.gov — Abbott Diabetes Care, Inc. — 722046 — 01/23/2026
These notes paraphrase and quote one public FDA warning letter. They are not legal advice. A warning letter is an administrative notice, not a court judgment. Redaction marks such as (b)(4) are FDA’s.