BEUDAMED
    FDA Recall Terminated

    Access Immunoassay Systems Assay Protocol: Dil-AFP.

    Recall: Z-1388-05 · Initiated July 18, 2005

    Recall

    Recall Number
    Z-1388-05
    Event Number
    32748
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    LOJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2005
    Posted
    August 23, 2005
    Terminated
    March 7, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Access Immunoassay Systems Assay Protocol: Dil-AFP.

    Reason

    Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results.

    Action

    Letters to customers were sent July 18, 2005. Firm will upgrade software later in the year. Customers are advised to not perform the automated dilution protocol but refer to the method in the directions.

    Distribution

    Nationwide and Canada

    Quantity

    311 USA 16 Canada