by Jameelah Mullen
December 4, 2025
Abbott’s FreeStyle Libre is a tool that measures glucose ranges by way of a sensor utilized to the higher again of the arm.
The Meals and Drug Administration (FDA) issued a warning about malfunctioning blood glucose monitoring units which were linked to seven deaths and greater than 700 severe accidents worldwide. The alert issued on Dec 2 notes that Abbott Diabetes Care glucose screens worldwide offered customers with incorrect glucose readings.
“If undetected, incorrect low glucose readings over an prolonged interval might result in flawed remedy choices for individuals dwelling with diabetes, akin to extreme carbohydrate consumption or skipping or delaying insulin doses,” the company stated. “These choices might pose severe well being dangers, together with potential harm or dying, or different much less severe problems.” The FDA notes in its alert.
The FDA considers this a “probably high-risk difficulty” and says it’ll proceed to replace its web site as extra data emerges.
Abbott additionally issued a warning stating that 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected. Libre3 readers and cellular apps are usually not impacted. No different Libre (FreeStyle Libre 14-day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Professional) or Abbott biowearables are affected by this difficulty.
“Abbott has recognized and resolved the reason for the difficulty, which pertains to one manufacturing line amongst a number of that make Libre 3 and Libre 3 Plus sensors. The corporate continues to provide Libre 3 and Libre 3 Plus sensors to meet alternative and new orders and doesn’t count on vital provide disruption,” the corporate acknowledged in a press launch.
Abbott advises its prospects to verify whether or not their sensors are affected and to cease utilizing the system and eliminate it instantly. The corporate additionally famous that among the many 60 accidents reported within the U.S., none have been deadly.
Sufferers can go to FreeStyleCheck.com to see if their sensors are affected and obtain a alternative for gratis.
In response to the Facilities for Illness Management and Prevention, about 38 million individuals within the U.S. reside with diabetes. The illness is the seventh main explanation for dying in the US.
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