BEUDAMED
    FDA Enforcement Class II Ongoing

    LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

    Recall: Z-0986-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0986-2026
    Event ID
    98079
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2025
    Initiation Date
    December 2, 2025
    Classification Date
    December 22, 2025
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

    Reason

    Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

    Code Info

    UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6

    Distribution

    Worldwide - US Nationwide.

    Quantity

    1 unit (16 additional units added 12/22/25)