BEUDAMED
    FDA Enforcement Class III Ongoing

    KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

    Recall: Z-2576-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2576-2023
    Event ID
    92878
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 20, 2023
    Initiation Date
    August 14, 2023
    Classification Date
    September 11, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

    Reason

    One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

    Code Info

    UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024

    Distribution

    US Nationwide distribution in the states of MN, PA, TN, TX.

    Quantity

    4 units