BEUDAMED
    FDA Enforcement Class II Terminated

    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

    Recall: Z-2983-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-2983-2020
    Event ID
    85874
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Biomedical GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2020
    Initiation Date
    June 17, 2020
    Classification Date
    September 18, 2020
    Termination Date
    August 24, 2022
    Address
    Sauerbruchstr. 50, N/A, Munich, N/A, N/A, Germany

    Description

    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

    Reason

    The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system .

    Code Info

    Serial/Lot Number(s)/Software Version: all

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of Illinois, Ohio, Pennsylvania, and West Virginia. The countries of Australia, Canada, China, Czech Republic, France, Israel, Italy, Germany, Switzerland, Spain, Netherlands, and United Kingdom.

    Quantity

    32 units