BEUDAMED
    FDA Enforcement Class II Ongoing

    KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

    Recall: Z-1483-2024 · Reported April 17, 2024

    Enforcement

    Recall Number
    Z-1483-2024
    Event ID
    94201
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 17, 2024
    Initiation Date
    March 6, 2024
    Classification Date
    April 5, 2024
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

    Reason

    The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.

    Code Info

    a) REF 0209P, UDI/DI 20845357003113, Lot Numbers: 209-37-1, 209-37-3, 209-37-4, 209-37-5; b) REF 0209K, UDI/DI 30845357003127, Lot Numbers: 209-37-2

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM, TN, PR, and the countries of France, Columbia, Kazakhstan, Peru, Puerto Rico, South Africa.

    Quantity

    19 units