The story has been updated to include comments from BioMérieux.
NEW YORK (360Dx) – BioMérieux is recalling two of its Vitek 2 gram-positive antimicrobial susceptibility testing cards due to false results for some strains of methicillin-resistant Staphylococcus aureus, the US Food and Drug Administration said today.
The agency said it has identified the recall as a Class I recall, the most serious type, as use of the cards may cause serious injuries or death.
The Vitek 2 Gram Positive Cefoxitin Screen and Vitek 2 Gram Positive AST for Oxacillin are reagent cards used with BioMérieux's Vitek 2 and Vitek 2 Compact systems to identify and conduct AST of bacteria and yeast. The results can then be used to determine appropriate antibiotic treatments for patients.
The FDA said that BioMérieux is recalling the cards because the cefoxitin screen card can provide false positive results for some strains of MRSA, while the oxacillin card can provide false susceptible results for the bacteria.
BioMérieux is investigating the root cause of the problem "and the prevalence of the strains that are subject to erroneous results," the FDA said, adding the company is providing interim mitigations during its investigation.
In a statement, the company said that it is not removing the affected items from the market, but instead, the recall comprises a two-step corrective action that BioMérieux is performing with its customers, including implementing a custom Vitek 2 System Software Bioart rule, and installing Vitek 2 Systems Software version 8.01, which has an optimized knowledgebase for the Vitek 2 cefoxitin screen test for improved detection of slow-growing MRSA.
The company also said that the initial customer complaints regarding the two cards occurred in France, followed by the UK, Germany, and "to a lesser degree," the US. "The complaints have centered around a very small number of S. aureus isolates worldwide," BioMérieux said.
BioMérieux manufactures 68 separate AST cards for the Vitek 2 systems containing oxacillin and cefoxitin, FDA noted.