BEUDAMED
    FDA Enforcement Class III Completed

    LYFO Disk

    Recall: Z-0788-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0788-2022
    Event ID
    89513
    Classification
    Class III
    Status
    Completed
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2022
    Initiation Date
    July 17, 2015
    Classification Date
    March 16, 2022
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    LYFO Disk

    Reason

    LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

    Code Info

    Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)

    Distribution

    Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.

    Quantity

    3 units