BEUDAMED
    FDA Enforcement Class II Ongoing

    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.

    Recall: Z-1075-2024 · Reported February 21, 2024

    Enforcement

    Recall Number
    Z-1075-2024
    Event ID
    93801
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2024
    Initiation Date
    January 8, 2024
    Classification Date
    February 12, 2024
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.

    Reason

    The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.

    Code Info

    Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448. UPDATE: The recall was expanded on 1/23/2024 to include the following additional lot numbers: 8184-65, exp. 3/31/2025; 8184-66, exp. 4/30/2025; 8184-67, exp. 5/31/2025; 8184-69, exp. 6/30/2025; 8184-70, exp. 8/31/2025; and 8184-71, exp. 8/31/2025.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY. There was government distribution and no military distribution. Foreign distribution was made to France.

    Quantity

    580 packages