A manufacturing problem in millions of Abbott glucose sensors has been tied to at least seven deaths and hundreds of injuries worldwide.
About 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors manufactured by Abbott were recalled in November, ...
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The FDA designated this a Class I Recall after 860 serious injuries and 7 deaths were reported related to falsely low glucose readings. Abbott Diabetes Care is recalling certain FreeStyle Libre 3 and ...
The US Food and Drug Administration has escalated the recall of specific Abbott FreeStyle Libre 3 and 3 Plus continuous glucose monitors to Class I, the highest level of urgency. The recall, which ...
This is now a Class I recall, meaning that the use of these continuous glucose monitoring systems could cause serious health consequences or death. Anna Gragert (she/her/hers) was previously the ...
Abbott is facing a warning letter from FDA regarding its Freestyle Libre family of continuous glucose monitoring (CGM) devices for use in diabetes management. The agency said it received responses ...
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The Food and Drug Administration has issued an alert concerning two glucose monitors with a “high-risk” sensor issue. Abbott Diabetes Care initiated a “medical device correction” on Nov. 24, for ...