BEUDAMED
    FDA Enforcement Class II Ongoing

    MicroScan Neg MIC 3J REF C54814

    Recall: Z-1772-2026 · Reported April 15, 2026

    Enforcement

    Recall Number
    Z-1772-2026
    Event ID
    98553
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 15, 2026
    Initiation Date
    June 25, 2025
    Classification Date
    April 3, 2026
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427, United States

    Description

    MicroScan Neg MIC 3J REF C54814

    Reason

    Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

    Code Info

    Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23

    Distribution

    International distribution in the country of Japan.

    Quantity

    688 boxes (20 panels per box)