BEUDAMED
    FDA Recall Terminated

    Mycoplasma genitalium Control Panel (Inactivated Pellet)

    Recall: Z-0784-2022 · Initiated February 25, 2022

    Recall

    Recall Number
    Z-0784-2022
    Event Number
    89694
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 25, 2022
    Terminated
    January 16, 2024
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Mycoplasma genitalium Control Panel (Inactivated Pellet)

    Reason

    Distributed product did not undergo proper release testing.

    Action

    All consignees were contacted beginning 02/25/2022 via email. Consignees should read the recall instructions and determine if the product can be used or discarded, depending on user's lab procedures. A response form should be completed and returned to [email protected].

    Distribution

    Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam

    Quantity

    80 units