BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

Recently, FDA announced that BioMérieux’s recall of the Vitek 2 AST Kit has been identified as Class I. The Vitek 2 AST kit, which includes the Gram-negative Susceptibility Card, is a test used to understand the susceptibility of certain types of bacteria to antibiotics.

Each card contains different antibiotics that have been dried with a special material for growing bacteria. The machine then watches how the bacteria grows in each individual well on the card for a set amount of time. After that set amount of time, it produces results showing the minimal inhibitory concentration (MIC) for most combinations of bacteria and drugs, as well as to whether the bacteria are susceptible, intermediate, or resistant to antibiotics.

BioMérieux is recalling the Vitek 2 AST cards, an antimicrobial sensitivity testing kit, due to incorrect concentrations of Ceftriaxone antibiotic in two wells. The two wells have been reported to have more of the antibiotic than designated. Use of the affected kits may cause serious adverse health consequences, according to the company, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and death. Of note, this recall is considered a correction, not a product removal.

On March 15, 2024, BioMérieux sent out an Urgent Field Safety Notice requesting that affected customers continue using the kits but suggesting the use of a different testing method if the results show that the MIC is in a range of 0.5, 1, or 2.

Currently, 49,276 kits (985,520 tests) have been recalled in the US in connection with this issue. The affected product was distributed between Dec. 12, 2023, and March 4, 2024. There have been no reports of injuries or deaths associated with the recall.