BEUDAMED
    FDA Enforcement Class II Terminated

    Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis.

    Recall: Z-0028-2018 · Reported October 25, 2017

    Enforcement

    Recall Number
    Z-0028-2018
    Event ID
    78177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cepheid
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2017
    Initiation Date
    September 15, 2017
    Classification Date
    October 18, 2017
    Termination Date
    July 28, 2023
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189, United States

    Description

    Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis.

    Reason

    Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.

    Code Info

    batch 1000045409 (lot 06802)

    Distribution

    USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay

    Quantity

    977 kits (9770 units)