BEUDAMED
    FDA Recall Terminated

    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

    Recall: Z-0176-2015 · Initiated October 6, 2014

    Recall

    Recall Number
    Z-0176-2015
    Event Number
    69437
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    October 6, 2014
    Posted
    November 6, 2014
    Terminated
    June 29, 2015
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

    Reason

    Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.

    Action

    An Urgent Medical Device Recall Letter dated 10/6/14 was sent to all customers who purchased the Small Form Factor Console PC for use with the Access 2 Immunoassay Systems Family. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside the US and Canada, customers are instructed to contact their local Beckman Coulter representative.

    Distribution

    Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, and Vietnam.

    Quantity

    1,519 units total (403 units total)