BioMérieux, Hazelwood, Mo, has recalled two products used to perform antimicrobial susceptibility testing (AST): the Vitek 2 gram-positive cefoxitin screen, and the Vitek 2 gram-positive AST for oxacillin.

The recall applies to all lots of gram-positive AST cards with cefoxitin and oxacillin tests, and includes products with manufacturing and distribution dates running from February 8, 2017, to August 23, 2018. FDA has identified the action as a Class I recall, which is the most serious type of recall. Use of the recalled devices may cause serious injury or death.

The company manufactures 68 separate Vitek 2 AST cards that contain cefoxitin and oxacillin. Gram-positive AST cards are reagent cards used with the bioMérieux Vitek 2 and Vitek 2 Compact systems to identify and conduct AST of bacteria and yeast, in order to assist in determining effective antibiotic treatment for patients with a bacterial infection. The Vitek 2 gram-positive cefoxitin screen and Vitek 2 gram-positive AST for oxacillin use the antibiotics cefoxitin and oxacillin to screen for methicillin-resistant Staphylococcus aureus (MRSA), a bacterial infection that can cause problems such as bloodstream infections, pneumonia, sepsis, or skin infections.

BioMérieux has indicated that the reason for the recall is the potential for the cards to produce false-negative or false-susceptible results for some strains of MRSA. The firm continues to investigate the issue to determine the root cause of the failure and the prevalence of the strains that are subject to erroneous results. The company is providing interim mitigations while the investigation is ongoing. The recall is not expected to cause a device shortage.

MRSA is a common cause of serious infections in the United States and worldwide. Missed diagnoses and inappropriate treatment of MRSA because of false-susceptibility or false-negative results could cause severe health consequences, including lack of treatment for a MRSA infection and death.

The recall affects hospitals and clinics that use the Vitek 2 system and gram-positive AST cards to screen for MRSA susceptibility as well as patients who are being screened. BioMérieux has issued a MRSA safety alert letter directing labs to:

  • Implement a custom Vitek 2 system software BIOART rule to aid in mitigating potential nondetection of MRSA when performing cefoxitin screen (OXSF) and oxacillin (OX) testing on Vitek 2 instruments.
  • Enable the advanced expert system on the Vitek 2 system software to ensure that the appropriate forcing rules are applied to test results regardless of the parameter set in use.
  • Use the existing strain submission system to send isolates of suspect strains of MRSA to bioMérieux for additional testing.

The company recommends that labs confirm potential MRSA upon activation of the software BIOART rule.

The recall was initiated on January 26, 2018. Healthcare professionals and consumers can report adverse reactions or quality problems they experience when using the devices to MedWatch, the FDA safety information and adverse event reporting program.


Featured Image: Digitally-colorized, scanning electron microscopic image of methicillin-resistant Staphylococcus aureus (MRSA) bacteria surrounded by cellular debris, produced by the National Institute of Allergy and Infectious Disease.