BEUDAMED
    FDA Recall Open, Classified

    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

    Recall: Z-2195-2025 · Initiated June 27, 2025

    Recall

    Recall Number
    Z-2195-2025
    Event Number
    97168
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 27, 2025
    Posted
    July 29, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

    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.

    Action

    Microbiologics issued an Urgent Medical Device Recall notice on 06/27/2025 via email. The notice explained the problem with the device, potential risk, and requested the following: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage. 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to [email protected]. 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Contact Recall Support team at 320.229.7080 or [email protected] with questions or concerns.

    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.