BEUDAMED
    FDA Recall Terminated

    Nichols Advantage TSH - Third Generation

    Recall: Z-0874-05 · Initiated April 28, 2005

    Recall

    Recall Number
    Z-0874-05
    Event Number
    31976
    Firm
    Nichols Institute Diagnostics
    FEI Number
    2050095
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2005
    Terminated
    March 16, 2012
    Address
    1311 Calle Batido, San Clemente, CA, 92673-6316

    Description

    Nichols Advantage TSH - Third Generation

    Reason

    Does not meet performance claims in the labeling.

    Action

    Firm sent recall letter and response form April 28, 2005. Firm will follow-up to nonrespondants.

    Distribution

    Nationwide, Germany, Greece and Spain

    Quantity

    1072