The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
- Name: VITEK 2 Gram Positive Cefoxitin Screen; VITEK 2 Gram Positive AST for Oxacillin
- Lot Numbers: All lots of gram positive AST cards with oxacillin and cefoxitin tests
- Manufacturing and Distribution Dates: February 8, 2017 to present
- Devices Recalled in the U.S.: 13,961,320 since February 8, 2017
Gram Positive AST Cards are reagent cards used with the BioMerieux VITEK 2 and VITEK 2 Compact Systems to identify and conduct antimicrobial susceptibility testing (AST) of bacteria and yeast, which helps determine an 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 skin infections, sepsis, pneumonia, or bloodstream infections.
BioMerieux manufactures 68 separate AST cards for the VITEK 2 Systems which contain oxacillin and cefoxitin.
Reason for Recall
BioMerieux is recalling the VITEK 2 Gram Positive Cefoxitin Screen and VITEK 2 Gram Positive AST for Oxacillin because of false negative or false susceptible, respectively, results for some strains of MRSA. The firm is continuing 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 firm is providing interim mitigations while the investigation is ongoing. This is not expected to cause a device shortage.
MRSA is a common cause of serious infections in the U.S. and worldwide, and 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.
Who May be Affected
Hospitals and clinics who use the VITEK 2 system and Gram Positive AST Cards to screen for MRSA susceptibility, and patients who are being screened.
What to Do
The firm issued a MRSA Safety Alert letter directing labs to:
- Implement a custom VITEK 2 System Software BIOART Rule to aid in mitigating potential non-detection of MRSA when testing oxacillin (OX) and cefoxitin screen (OXSF) on VITEK 2,
- Enable the Advanced Expert System on the VITEK 2 Systems software to ensure that the appropriate forcing rules are applied to test results regardless of the parameter set in use, and
- Use the existing strain submission system to send isolates of suspect strains of MRSA to bioMérieux for additional testing.
The firm recommends that labs confirm potential MRSA upon activation of the software BIOART rule.
595 Anglum Road
Hazelwood, MO 63042-2320
Date Recall Initiated
January 26, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.