BEUDAMED
    FDA Recall Open, Classified

    DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    Recall: Z-1546-2024 · Initiated March 5, 2024

    Recall

    Recall Number
    Z-1546-2024
    Event Number
    94191
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 5, 2024
    Posted
    August 30, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    Reason

    Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

    Action

    Beckman Coulter notified consignees on 03/05/2024 via FedEx and email. The letter outlined the reason for the recall and requested consignees to review inventory for affected units. If any affected units are identified, to inspect the area underneath the wash buffer drawer for evidence of leaking wash buffer. If leaking or pooling is observed, clean up liquid wearing appropriate Personal Protective Equipment (PPE), discontinue the use of the DxI 9000, and contact your Beckman Coulter representative immediately. If no leaking or pooling of Wash Buffer in observed, continue operating the instrument as normal and continue to monitor for leaking. A Field Service Representative will contact customers to replace the internal wash buffer tank on the affected instruments. Consignees were also instructed to share this information with laboratory staff, notify any customers if further distributed, and complete and return the response form.

    Distribution

    Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.

    Quantity

    17 units