BEUDAMED
    FDA Enforcement Class II Terminated

    Access Immunoassay Systems Reaction Vessels. 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-0519-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0519-2014
    Event ID
    66521
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    October 2, 2013
    Classification Date
    December 16, 2013
    Termination Date
    October 23, 2014
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Access Immunoassay Systems Reaction Vessels. 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

    Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). I

    Code Info

    Part Number 81901, Lot Numbers: 13181168-13341170.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.

    Quantity

    16,154 units