BEUDAMED
    FDA Recall Terminated

    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.

    Recall: Z-0304-2021 · Initiated October 8, 2020

    Recall

    Recall Number
    Z-0304-2021
    Event Number
    86576
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    JTR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 8, 2020
    Terminated
    November 17, 2022
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    Description

    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.

    Reason

    QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

    Action

    The recalling firm is sending consignees recall notification letters beginning 10/08/2020 via email. The correction communication was first extended to the first level of the distribution change (those who received product directly from Microbiologics). Distributors outside of the US will be contacted via email, and if follow up is necessary, the recalling firm's international sales team will work with each distributor to ensure this communication is extended to their end users. The recalling firm is working with its European Authorized Representative to coordinate this field safety corrective action in the EU.

    Distribution

    Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.

    Quantity

    5 units