BEUDAMED
    FDA Recall Terminated

    Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200

    Recall: Z-1313-06 · Initiated April 12, 2006

    Recall

    Recall Number
    Z-1313-06
    Event Number
    35630
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    DHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2006
    Posted
    August 1, 2006
    Terminated
    April 3, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200

    Reason

    Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.

    Action

    A Product Corrective Action letter was sent via US mail the week of April 10, 2006 to all Access CEA customers informing them that the Access CEA Assay could generate decreased values with certain frozen patient specimens. Although they have found it at a low occurrence, it is recommended that specimens should not be frozen prior to analysis until further notice. The letter informs customers that Beckman Coulter has verified sample stability through at least 14 days when properly stored at 2-8 degrees Celsius and shipping stability for 4 days at 2-8 degrees Celsius using cool packs. Firm also advises customers to contact customer technical support or local Beckman Coulter Representative if laboratory is unable to avoid freezing specimens and to review results from frozen CEA samples to ensure that the match the total clinical presentation per the customer''s established laboratory procedure. The letter requests that the notification remain part of the laboratory Quality System documentation and that the response form be returned to the firm within 10 days.

    Distribution

    Nationwide and Canada

    Quantity

    775