BEUDAMED
    FDA Enforcement Class III Ongoing

    Cepheid Xpert C. difficile/Epi Control Panel

    Recall: Z-1838-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1838-2019
    Event ID
    82787
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 26, 2019
    Initiation Date
    May 16, 2019
    Classification Date
    June 18, 2019
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    Cepheid Xpert C. difficile/Epi Control Panel

    Reason

    Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

    Code Info

    UDI: 70845357041370, Lot Number 8200-26

    Distribution

    NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO

    Quantity

    22 units