BEUDAMED
    FDA Enforcement Class II Terminated

    The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.

    Recall: Z-2618-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2618-2014
    Event ID
    68991
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    July 23, 2014
    Classification Date
    September 10, 2014
    Termination Date
    May 9, 2016
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.

    Reason

    The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.

    Code Info

    All Lots with the expiration date January 21, 2014 or later

    Distribution

    US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.

    Quantity

    585,048 tests