The U.S. Food and Drug Administration (FDA) on Wednesday categorized a product recall initiated by Abbott Laboratories (ABT) affecting certain lots of its glucose monitor sensors as the most serious type after seven deaths linked to the issue.
The announcement came after Abbott (ABT) reported that faulty glucose readings tied to some of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors have caused 860 serious injuries and seven deaths as of Jan. 7.
The company has informed the patients impacted by the recall through letters sent on Nov. 25. According to Abbott (ABT), the faulty devices can cause inaccurate clinical decisions impacting people with diabetes if incorrect readings go undetected in the long term, leading to findings of lower than actual blood glucose levels.
The FDA provided a link to the list of affected product lots and advised patients to immediately discontinue the use of FreeStyle Libre 3 if their products are included in the recall.