BEUDAMED
    FDA Enforcement Class II Ongoing

    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

    Recall: Z-2194-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2194-2025
    Event ID
    97168
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 6, 2025
    Initiation Date
    June 27, 2025
    Classification Date
    July 29, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

    Reason

    KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

    Code Info

    1) 0894K: UDI/DI 30845357021954, Lot Numbers: 894-76-81; 2) 0894P: UDI/DI 20845357021940, Lot Numbers: 894-76-21, 894-76-51, 894-76-52.

    Distribution

    Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.

    Quantity

    32 units