BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0239-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0239-2016
    Event ID
    72408
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    October 13, 2015
    Classification Date
    November 6, 2015
    Termination Date
    April 13, 2016
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    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.

    Code Info

    595027 595029

    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)