BEUDAMED
    FDA Recall Open, Classified

    KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493

    Recall: Z-1957-2025 · Initiated May 27, 2025

    Recall

    Recall Number
    Z-1957-2025
    Event Number
    96974
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 27, 2025
    Posted
    June 11, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493

    Reason

    Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

    Action

    On May 27, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed of the affected products containing the wrong microorganisms. Customers were instructed to review lab procedures to understand how this information affects their usage, and then to use or discard the product depending on the lab procedures and how the issue affects usage. Distributors of the affected product were instructed to contact end users who have received the affected items.

    Distribution

    US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.

    Quantity

    3 total