BEUDAMED
    FDA Recall Terminated

    DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.

    Recall: Z-2882-2011 · Initiated September 9, 2010

    Recall

    Recall Number
    Z-2882-2011
    Event Number
    57968
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JKC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 9, 2010
    Posted
    July 26, 2011
    Terminated
    May 4, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    DHEA RIA Reagent The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.

    Reason

    The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient samples.

    Action

    Beckman Coulter sent an "URGENT: PRODUCT CORRECTION ACTION" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol, 17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was enclosed for customers to complete and return. Contact the Beckman Coulter Technical Support Center at 1-800-854-3633 in the United States, or their local Beckman Coulter Representative for questions regarding this notification.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.

    Quantity

    3,542 units (1181 in US)