BEUDAMED
    FDA Recall Terminated

    Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.

    Recall: Z-1898-2010 · Initiated April 5, 2010

    Recall

    Recall Number
    Z-1898-2010
    Event Number
    55670
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    NQX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 5, 2010
    Posted
    July 1, 2010
    Terminated
    May 25, 2011
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

    Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.

    Reason

    The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.

    Action

    The firm, Cepheid, issued a technical bulletin to customers on April 5, 2010 and an updated to the April 5 bulletin dated April 9, 2010 instructing them to perform a reflexive repeat test on any blood culture results initially determined as having SA. If further information on this please contact your Cepheid Sales Representative 1-888-336-2743 or www.CEPHEID.COM.

    Distribution

    Worldwide distribution: USA and Europe, Taiwan, and Australia.

    Quantity

    5,510 units