BEUDAMED
    FDA Enforcement Class II Ongoing

    DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

    Recall: Z-1597-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1597-2023
    Event ID
    92056
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2023
    Initiation Date
    April 5, 2023
    Classification Date
    May 17, 2023
    Address
    11800 Sw 147th Ave, N/A, Miami, FL, 33196-2500, United States

    Description

    DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

    Reason

    Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

    Code Info

    UDI/DI 15099590748647, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6

    Distribution

    Worldwide Distribution

    Quantity

    107 units