BEUDAMED
    FDA Enforcement Class II 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 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2548-2016
    Event ID
    74803
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cepheid
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    July 18, 2016
    Classification Date
    August 16, 2016
    Termination Date
    September 30, 2016
    Address
    904 E Caribbean Dr, N/A, Sunnyvale, CA, 94089-1189, United States

    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.

    Code Info

    Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).

    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.