BEUDAMED
    FDA Recall Terminated

    Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.

    Recall: Z-1118-04 · Initiated June 30, 2004

    Recall

    Recall Number
    Z-1118-04
    Event Number
    29504
    Firm
    Nichols Institute Diagnostics
    FEI Number
    2050095
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2004
    Posted
    February 24, 2005
    Terminated
    February 10, 2012
    Address
    1311 Calle Batido, San Clemente, CA, 92673-6316

    Description

    Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.

    Reason

    Lower than expected results are obtained.

    Action

    Firm sent Customer Bulletin No 04-09-AD on June 30, 2004. It addresses the issues and advises customers as to alternative actions, including appending results with a caution statement regarding low recovery.

    Distribution

    Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France.

    Quantity

    Not Applicable.