BEUDAMED
    FDA Recall 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 · Initiated March 25, 2013

    Recall

    Recall Number
    Z-0641-2022
    Event Number
    89479
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 25, 2013
    Terminated
    April 22, 2022
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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.

    Action

    Microbiologics notified customers on 03/25/2013 via letter titled "Important Medical Device Correction". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (KWIK-STIK" 01023P, Lot# 1023-05-7), it is recommended that the customer destroys the product. Microbiologics shall replace the destroyed product upon confirmation of destruction. Questions or concerns can be directed to the Customer Service Manager at 320.229.7057.

    Distribution

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

    Quantity

    10 units