BEUDAMED
    FDA Enforcement Class II Terminated

    DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

    Recall: Z-2602-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2602-2021
    Event ID
    88519
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    July 21, 2021
    Classification Date
    September 30, 2021
    Termination Date
    October 10, 2024
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

    Reason

    There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).

    Code Info

    Affected US Serial Numbers: T23000077, T23000075, T23000076, T23000074, T23000069, T23000070, T23000066, T23000099, T23000096, T23000098, T23000100, T23000095, T23000097, T23000101, T23000092, T23000091, T23000090, T23000142, T23000045, T23000040, T23000039, T23000038, T23000152, T23000154, T23000155, T23000153, T23000106, T23000108, T23000107, T23000109, T23000128, T23000124, T23000125, T23000126, T23000115, T23000116, T23000113, T23000112, T23000117, T23000114, T23000132, T23000133, T23000131, T23000134, T23000064, T23000065, T23000063, T23000062, T23000163, T23000164, T23000162, T23000173, T23000169, T23000161, T23000138, T23000136, T23000137, T23000094, T23000093, T23000135, T23000141, T23000139, T23000140, T23000166, T23000168, T23000167, T23000082, T23000081, T23000080, T23000085, T23000084, T23000083, T23000143, T23000146, T23000145, T23000144

    Distribution

    US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV.

    Quantity

    123 systems