BEUDAMED
    FDA Recall Open, Classified

    KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

    Recall: Z-2124-2025 · Initiated June 17, 2025

    Recall

    Recall Number
    Z-2124-2025
    Event Number
    97096
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 17, 2025
    Posted
    July 17, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

    Reason

    Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

    Action

    On June 17. 2025, the firm began notifying affected customers via "Urgent Medical Device Recall" letters delivered through email. Customers were instructed to review lab procedures to understand how the information may affect usage; use or discard product depending on lab procedures. Complete and return the response form to [email protected]. If product was further distributed or transferred to other facilities or customers, they should also be notified. Customers may contact Microbiologics if a replacement kit is needed. If you have any questions or concerns, contact Recall Support team at 320.229.7080 or [email protected]. Collect calls may be made.

    Distribution

    US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.

    Quantity

    21 total