NEW YORK – The US Food and Drug Administration said on Friday that Thermo Fisher Scientific subsidiary Remel has recalled its Gram Negative IVD AST Sensititre Plates that have been distributed since January 2021 for potential false indications of drug susceptibility among Proteae tribe bacteria.
The FDA said on its website that the recall, which was initiated on Oct. 20, affects about 19,000 Sensititre products distributed from Jan. 26, 2021, through Oct. 16, 2022. The bacteria growth plates are used by healthcare and laboratory personnel to test the antimicrobial susceptibility of non-fastidious Gram-negative Enterobacterales, Pseudomonas aeruginosa, and other non-Enterobacteriaceae. The recalled plates could deliver false susceptible results for Proteae tribe organisms including Proteus and Providencia species and Morganella morganii to carbapenem, cefepime, piperacillin/tazobactam, and aztreonam antibiotics.
"A false susceptibility result could lead patients to receive an ineffective treatment and experience serious injury or health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death," the agency said. The FDA has classified the recall a Class I recall, the most severe kind.
The FDA has received five reports of problems with the products, and Remel has received one complaint, although none related to any known deaths or injuries, the FDA said. On Oct. 25, Remel sent customers a letter that urged them not to report any results for Proteae tribe bacteria because of the risk of false results, and the company will update its instructions for using those products.