BEUDAMED
    FDA Recall Terminated

    UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI 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-2259-2012 · Initiated October 13, 2011

    Recall

    Recall Number
    Z-2259-2012
    Event Number
    62706
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 13, 2011
    Posted
    August 23, 2012
    Terminated
    August 23, 2012
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI 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 recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.

    Action

    The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 with attached PCA Response Form to all customers who purchased the UniCel Dxl Immunoassay Systems and DxC Clinical Systems which includes all software versions. The letter describes the product, problem and actions to be taken. The customers were instructed verify the system temperatures immediately following each initialization; do not begin processing samples until this verification is complete; refer to the appendix included with the letter for detailed instructions about verifying system temperatures; review their quality control (QC) performance history; and share this information with their staff and retain this information as part of their quality system documentation, and to complete and return the enclosed response form within 10 days to Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318; Attn: Regulatory Affairs or fax to: 1-786-639-4000. Customers with any questions regarding the notice, were instructed to contact Customer Support Center via our website, http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representatives.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea,Republic of; Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

    Quantity

    2442 units total (784 units in US)