BEUDAMED
    FDA Enforcement Class II Ongoing

    MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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-1609-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1609-2026
    Event ID
    98555
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2026
    Initiation Date
    July 24, 2025
    Classification Date
    March 20, 2026
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427, United States

    Description

    MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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 the likely presence of contamination in well(s).

    Code Info

    Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.

    Quantity

    685 boxes