BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2124-2025 · Reported July 23, 2025

    Enforcement

    Recall Number
    Z-2124-2025
    Event ID
    97096
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 23, 2025
    Initiation Date
    June 17, 2025
    Classification Date
    July 17, 2025
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    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.

    Code Info

    Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544

    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