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 have been linked to seven deaths and greater than 700 severe accidents worldwide. The alert issued on Dec 2 notes that Abbott Diabetes Care glucose displays worldwide supplied customers with incorrect glucose readings.
“If undetected, incorrect low glucose readings over an prolonged interval could result in mistaken remedy choices for folks dwelling with diabetes, resembling extreme carbohydrate consumption or skipping or delaying insulin doses,” the company stated. “These choices could pose severe well being dangers, together with potential harm or demise, or different much less severe issues.” The FDA notes in its alert.
The FDA considers this a “probably high-risk difficulty” and says it can proceed to replace its web site as extra info emerges.
Abbott additionally issued a warning stating that 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors are affected. Libre3 readers and cell apps should 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 substitute and new orders and doesn’t anticipate vital provide disruption,” the corporate said in a press launch.
Abbott advises its clients to test whether or not their sensors are affected and to cease utilizing the machine and get rid of it immediately. 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 substitute for gratis.
Based on the Facilities for Illness Management and Prevention, about 38 million folks within the U.S. are dwelling with diabetes. The illness is the seventh main explanation for demise in america.
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