BEUDAMED
    FDA Recall Terminated

    Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.

    Recall: Z-0711-2011 · Initiated November 10, 2010

    Recall

    Recall Number
    Z-0711-2011
    Event Number
    57230
    Firm
    Diagnostic Chemicals, Ltd.
    FEI Number
    3002806809
    Product Code
    CHH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 10, 2010
    Posted
    December 16, 2010
    Terminated
    September 19, 2011
    Address
    16 McCarville Street, Charlottetown Canada

    Description

    Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.

    Reason

    Cholesterol Reagent bottles labels reversed for R1 and R2

    Action

    Genzyme Diagnostics P.E.I. Inc. sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated November 10, 2010, via Federal Express to customers. The letter described the label error and requested that the reagents not be interchanged with another reagent lot. The firm ask that the customers complete and return the attached IMPORTANT PRODUCT FIELD CORRECTION confirmation of notification via fax at 902-628-6504. Contact a Genzyme Diagnostics Technical Services Representative at 1-800- 565-0265, if you require further information, or if you have any questions.

    Distribution

    Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.

    Quantity

    30 kits