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FDA Issues Class I Recall of BioMérieux Vitek 2 AST Cards

NEW YORK – The US Food and Drug Administration said Wednesday that BioMérieux is recalling its Vitek 2 antimicrobial sensitivity testing kits due to incorrect concentrations of an antimicrobial. The FDA has identified the recall as Class I — the most serious type — and customers are advised to use an alternative method if they obtain certain test results.

Lots of Vitek 2 AST cards distributed between December 12, 2023, and March 4, 2024, may contain higher concentration of the antibiotic ceftriaxone in two wells, the FDA said in a medical device recall notice.

BioMérieux initiated a recall of the AST cards, for use on the firm's Vitek 2 automated AST system, on March 14 by sending customers an urgent field safety notice.

The issue, which another FDA document notes was due to employee error, results in the potential for false susceptibility results for isolates that have a 0.5, 1, or 2 ceftriaxone minimum inhibitory concentration (MIC) result. A total of 49,215 AST cards distributed globally are affected by the recall.

A Class I recall indicates that the use of the affected kits may cause "serious adverse health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and death," the FDA said.

Customers are advised to continue using the kits and to consider an alternative method to determine MIC if the Vitek 2 AST card results in MIC of 0.5, 1, or 2, the FDA said.

The Vitek 2 AST card recall is a correction, not a product removal, the FDA also said, and there have been no reports of injuries or deaths associated with this issue.