BEUDAMED
    FDA Recall Terminated

    UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

    Recall: Z-0985-2014 · Initiated November 26, 2013

    Recall

    Recall Number
    Z-0985-2014
    Event Number
    66958
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 26, 2013
    Posted
    February 16, 2014
    Terminated
    July 27, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

    Reason

    The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

    Action

    Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.

    Distribution

    Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.

    Quantity

    1 unit