BEUDAMED
    FDA Recall Terminated

    Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040

    Recall: Z-0810-05 · Initiated April 7, 2005

    Recall

    Recall Number
    Z-0810-05
    Event Number
    31730
    Firm
    Nichols Institute Diagnostics
    FEI Number
    2050095
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 7, 2005
    Posted
    May 10, 2005
    Terminated
    March 16, 2012
    Address
    1311 Calle Batido, San Clemente, CA, 92673-6316

    Description

    Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040

    Reason

    Values do not agree with Directional Instructions.

    Action

    Firm sent separate notices for each lot of product to customers dated March 25, 2005 requesting destruction of remaining product and affirmation of that activity via a response form. Users were also provided detailed listing of performance characteristics related to the deficiencies for thier information and evaluation per thier own lab''s SOP''s.

    Distribution

    Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden

    Quantity

    13751