Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning VITEK 2 Gram Positive Cefoxitin Screen and 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: 8 February 2017 to present], manufactured by BioMerieux.

The manufacturer is recalling the affected products because of false negative or false susceptible results for some strains of methicillin-resistant Staphylococcus aureus (MRSA). It 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.

According to the manufacturer, missed diagnosis and inappropriate treatment of MRSA could cause severe health consequences, including lack of treatment for a MRSA infection, and death.

The manufacturer recommends that labs confirm potential MRSA upon activation of the software BIOART rule. The MRSA Safety Alert letter is issued 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 the manufacturer for additional testing.

For details, please refer to the following FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm618135.htm

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 24 August 2018