Medtech Recall Round-Up: May 2024

BioMérieux Vitek AST Kit

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.

BioMérieux recalled 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. There have been no reports of injuries or deaths associated with the recall.