BEUDAMED
    FDA Recall Open, Classified

    Cepheid Xpert C. difficile/Epi Control Panel

    Recall: Z-1838-2019 · Initiated May 16, 2019

    Recall

    Recall Number
    Z-1838-2019
    Event Number
    82787
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    PMN
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    May 16, 2019
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Cepheid Xpert C. difficile/Epi Control Panel

    Reason

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

    Action

    The firm initiated the recall by email on 05/20/2019. The notice requested the consignee relabel the product with the correct date and return the completed response form.

    Distribution

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

    Quantity

    22 units