BEUDAMED
    FDA Recall Terminated

    Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

    Recall: Z-1737-2014 · Initiated May 14, 2014

    Recall

    Recall Number
    Z-1737-2014
    Event Number
    68309
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 14, 2014
    Posted
    June 9, 2014
    Terminated
    December 25, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

    Reason

    Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.

    Action

    Beckman Coulter sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 8, 2014 via first class mail. The letter identified the reason for recall, product information, issue, impact, action, resolution, contact information, and customer response form. Customers are advised to review historical quality control (QC) data and System Check results, and determine whether a review of patient test results is warranted. For questions regarding this letter, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com/customersupport/support, By phone: call 1-800-854-3633 in the United States and Canada, and Outside the United States and Canada, contact your local Beckman Coulter representative

    Distribution

    Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.

    Quantity

    82 units