BEUDAMED
    FDA Recall Terminated

    Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization

    Recall: Z-2548-2016 · Initiated July 18, 2016

    Recall

    Recall Number
    Z-2548-2016
    Event Number
    74803
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    NQX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 18, 2016
    Terminated
    September 30, 2016
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

    Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization

    Reason

    Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.

    Action

    Recall letters dated July 18, 2016 were sent to affected customers on July 19, 2016 by Federal Express. Letters advised users of the affected product and asked that any remaining inventory be destroyed.

    Distribution

    US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC.

    Quantity

    68 kit for lot 1000037539 and 127 kit s for lot 1000029307.