BEUDAMED
    FDA Enforcement Class III Terminated

    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.

    Recall: Z-0637-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0637-2022
    Event ID
    89412
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 16, 2022
    Initiation Date
    March 2, 2017
    Classification Date
    February 10, 2022
    Termination Date
    April 22, 2022
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.

    Reason

    Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

    Code Info

    Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728

    Distribution

    International distribution in the countries of Canada and Germany.

    Quantity

    1 unit