Abbott Diabetes Care has advised that certain glucose monitor sensors be removed from use or sale after the FDA classified the action as its most serious type of recall.
The recall involves specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors with model numbers 72081-01, 72080-01, 78768-01 and 78769-01 and associated UDI-DIs 00357599818005, 00357599819002, 00357599844011 and 00357599843014.
Abbott on Nov. 24 instructed distributors, healthcare providers and affected customers to discontinue use of the sensors and dispose of them.
Abbott recalled the devices after determining they could produce glucose readings that are lower than actual blood glucose levels. If undetected, the incorrect glucose readings over an extended period may lead to wrong treatment decisions that may pose serious health risks, including potential injury or death, or other less serious complications, the FDA said in a news release.
As of Jan. 7, the company reported 860 serious injuries and seven deaths linked to the issue, according to the FDA release.
The affected sensors were indicated for people 4 and older. Other FreeStyle Libre products, including readers and mobile apps, were not affected.
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