BEUDAMED
    FDA Enforcement Class II Ongoing

    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    Recall: Z-1794-2026 · Reported April 15, 2026

    Enforcement

    Recall Number
    Z-1794-2026
    Event ID
    98562
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2026
    Initiation Date
    September 8, 2025
    Classification Date
    April 8, 2026
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427, United States

    Description

    MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    Reason

    Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

    Code Info

    Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08

    Distribution

    International distribution to the country of Poland.

    Quantity

    3 boxes