BEUDAMED
    FDA Recall Terminated

    Nichols Advantage ACTH Test System, catalog number 62-7004.

    Recall: Z-1044-05 · Initiated April 22, 2005

    Recall

    Recall Number
    Z-1044-05
    Event Number
    32042
    Firm
    Nichols Institute Diagnostics
    FEI Number
    2050095
    Product Code
    CKG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 22, 2005
    Posted
    July 28, 2005
    Terminated
    March 16, 2012
    Address
    1311 Calle Batido, San Clemente, CA, 92673-6316

    Description

    Nichols Advantage ACTH Test System, catalog number 62-7004.

    Reason

    Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.

    Action

    Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.

    Distribution

    Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden

    Quantity

    1203