Abbott Laboratories announced a U.S. correction for its FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors after internal testing revealed that a subset of devices could report falsely low glucose readings, potentially leading patients to underestimate hypoglycemia and delay insulin or carbohydrate correction.
The company identified a manufacturing defect that caused the erroneous low‑reading signal and has resolved the issue. The correction covers roughly 3 million sensors from a specific production line; about half of those units have expired or been used. Global reports show 736 severe adverse events linked to the defect, including 57 in the United States and seven deaths worldwide, none of which occurred in the U.S. The recall‑style program allows affected sensors to be replaced or repaired at no cost to consumers, and Abbott is monitoring the situation closely with the FDA.
FreeStyle Libre sales are a core component of Abbott’s Diabetes Care segment, which generated $1.7 billion in Q1 2025 and $1.6 billion in Q2 2024, representing 20–25% year‑over‑year growth. The sensor line accounts for a large share of the $11.37 billion in total company sales reported in Q3 2025. A disruption in this product line could erode market share in the highly competitive CGM market, where Dexcom and other players vie for dominance.
The recall underscores the importance of accuracy in glucose monitoring devices. While the current correction involves falsely low readings—distinct from the Class I recall in September 2024 that addressed falsely high readings—any safety issue can damage patient trust and open the door for competitors. Abbott’s swift response and no‑cost replacement program aim to mitigate reputational risk and maintain clinician confidence in the FreeStyle Libre platform.
Regulatory authorities are closely monitoring Abbott’s corrective actions. The FDA’s classification of the earlier issue as a Class I recall highlights the seriousness of such events, and Abbott’s current program demonstrates its commitment to product safety and regulatory compliance. The company will continue to track adverse event reports and collaborate with regulators to ensure the long‑term reliability of its CGM devices.
Abbott’s leadership has emphasized that the root cause has been identified and that the manufacturing process has been corrected. The company’s focus on rapid remediation and transparent communication reflects its broader strategy to sustain growth in the diabetes care market while safeguarding patient safety.
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