BEUDAMED
    FDA Recall Terminated

    KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.

    Recall: Z-0544-2022 · Initiated February 24, 2021

    Recall

    Recall Number
    Z-0544-2022
    Event Number
    89380
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 24, 2021
    Posted
    January 31, 2022
    Terminated
    July 11, 2022
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.

    Reason

    Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.

    Action

    Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3.COMPLETE the response form provided; 4. RETURN the response form to [email protected]; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or [email protected].

    Distribution

    US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.

    Quantity

    47 packs (94 units)