BEUDAMED
    FDA Recall Terminated

    Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.

    Recall: Z-0056-06 · Initiated April 14, 2005

    Recall

    Recall Number
    Z-0056-06
    Event Number
    31917
    Firm
    Nichols Institute Diagnostics
    FEI Number
    2050095
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2005
    Posted
    October 15, 2005
    Terminated
    March 16, 2012
    Address
    1311 Calle Batido, San Clemente, CA, 92673-6316

    Description

    Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.

    Reason

    Controls were out of specification range.

    Action

    Recall letter and response form was sent on April 14, 2005 to all domestic and foreign consignees.

    Distribution

    Nationwide, Japan, Spain, Germany and Sweden

    Quantity

    323