BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2576-2023 · Initiated August 14, 2023

    Recall

    Recall Number
    Z-2576-2023
    Event Number
    92878
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    August 14, 2023
    Posted
    September 11, 2023
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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.

    Action

    Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed.

    Distribution

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

    Quantity

    4 units