BEUDAMED
    FDA Recall Terminated

    Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.

    Recall: Z-0239-2016 · Initiated October 13, 2015

    Recall

    Recall Number
    Z-0239-2016
    Event Number
    72408
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    DHX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 13, 2015
    Posted
    November 6, 2015
    Terminated
    April 13, 2016
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.

    Reason

    Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

    Action

    An Urgent Medical Device Recall letter dated 10/13/15 was sent to all customers who purchased the Access CEA Reagent Kit to inform them that Beckman Coulter has determined that the Access CEA reagent packs (P/N 33200) were filled incorrectly. The packs contain insufficient quantity of reagents in one of the pack wells. The letter informs the customers of the impact 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 Beckman Coulter's Customer Technical Support at http://www.beckmancoulter.com, (800) 854-3633 in the US and Canada. Customers outside of the US and Canada are instructed to contact their local Beckman Coulter representative.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Germany, Ghana, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Mexico, Morocco, Myanmar, Netherlands, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

    Quantity

    11,406 units total (1,660 units)