BEUDAMED
    FDA Enforcement Class III Terminated

    KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)

    Recall: Z-0641-2022 · Reported February 23, 2022

    Enforcement

    Recall Number
    Z-0641-2022
    Event ID
    89479
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 23, 2022
    Initiation Date
    March 25, 2013
    Classification Date
    February 14, 2022
    Termination Date
    April 22, 2022
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)

    Reason

    Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.

    Code Info

    Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.

    Quantity

    10 units