BEUDAMED
    FDA Recall Completed

    LYFO Disk

    Recall: Z-0788-2022 · Initiated July 17, 2015

    Recall

    Recall Number
    Z-0788-2022
    Event Number
    89513
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Completed
    Root Cause
    Labeling mix-ups
    Initiated
    July 17, 2015
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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.

    Action

    Microbiologics notified customers on 07/17/2015 via letter titled "Medical Device Recall". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (LYFO DISK 0983L, Lot# 983-40-3), it is recommended that the customer destroys the product or return it to the recalling firm. Acknowledgement of the receipt of the recall letter was requested by completing a form and returning to Microbiologics. Questions or concerns can be directed to the Quality Systems Manager at 320.229.7050.

    Distribution

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

    Quantity

    3 units