BEUDAMED
    FDA Recall Open, Classified

    KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

    Recall: Z-0876-2026 · Initiated November 13, 2025

    Recall

    Recall Number
    Z-0876-2026
    Event Number
    97987
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 13, 2025
    Posted
    December 2, 2025
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

    Reason

    Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

    Action

    An Urgent Medical Device Recall notification letter dated 11/13/25 was sent to customers. INSTRUCTIONS: 1.CONTACT END USERS who have received or may have received the affected items above and provide them with the Customer Communication and Customer Response Forms. 2.COMPLETE the Distributor Response Form provided. 3.RETURN the response forms to [email protected]. 4.KEEP this letter for your records. 5.CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns. Collect calls may be made.

    Distribution

    International distribution to the countries of UAE, China, Singapore, Kazakhstan,

    Quantity

    5 units