BEUDAMED
    FDA Enforcement Class II Terminated

    Inactivated macrolide-resistant Mycoplasma genitalium

    Recall: Z-0955-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0955-2022
    Event ID
    89887
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 27, 2022
    Initiation Date
    March 22, 2022
    Classification Date
    April 19, 2022
    Termination Date
    January 9, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    Inactivated macrolide-resistant Mycoplasma genitalium

    Reason

    The QC process was not adequate for the specification range.

    Code Info

    Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003

    Distribution

    US Nationwide distribution in the states of NV and VT.

    Quantity

    2 ea