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The Meals and Drug Administration (FDA) issued a stark warning Tuesday about malfunctioning blood glucose monitoring units that will have contributed to seven deaths and lots of of significant accidents.
Medical tools producer Abbott additionally alerted customers and well being distributors final Monday, urging them to right away cease utilizing or eliminate all FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor units.
The FDA described the difficulty as a “potentially high-risk” drawback.
“As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths associated with this issue,” the FDA mentioned. Abbott famous that 57 of the “severe adverse events” occurred within the U.S., and not one of the deaths came about within the nation.
DIABETES STUDY REVEALS DIAGNOSIS GAP AFFECTING MILLIONS OF PEOPLE
Diabetic teen geared up with glucose sensor. (BSIP/Common Photos Group / Getty Photos)
Each the FDA and Abbott warned that the displays might “provide incorrect low glucose readings” and suggested sufferers to test whether or not their sensors are affected.
“Abbott initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. after internal testing determined that some of these sensors may provide incorrect low glucose readings,” Abbott advised FOX Enterprise Tuesday.
“If undetected, incorrect low glucose readings over an extended period may lead to improper treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” the FDA and Abbott mentioned. “These decisions can pose serious health risks, including potential injury or death, as well as other less severe complications.”
OZEMPIC AND SIMILAR DRUGS COULD INTERFERE WITH COMMON MEDICAL PROCEDURE, RESEARCH WARNS
4-year-old little one reveals a blood glucose sensor on his arm that measures his blood glucose in Berlin, Germany, on Aug. 3, 2021. (Jörg Carstensen/image alliance / Getty Photos)
The sensors concerned are real-time monitoring units with alarm capabilities, designed to assist handle diabetes in people aged 4 and older.
Abbott mentioned the corporate has recognized and resolved the manufacturing difficulty associated to those units, noting that the issue impacts just one manufacturing line out of a number of used to make the sensors. Roughly 3 million sensors from the affected line are impacted, the corporate mentioned.
The producer mentioned it can produce new units to meet alternative and new orders and that the corporate doesn’t anticipate important provide disruptions.
Ticker Safety Final Change Change % ABT ABBOTT LABORATORIES 126.32 -1.75
-1.37%
Customers can go to www.FreeStyleCheck.com to find out if their sensors are affected and to acquire a alternative at no cost, Abbott added.
Abbott Laboratories signage seen at its campus headquarters in Abbott Park, Illinois, on Friday, Might 21, 2010. (Tim Boyle/Bloomberg / Getty Photos)
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The corporate emphasised that no different Libre household sensors, readers or apps are affected.
