BEUDAMED
    FDA Recall Terminated

    AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catalogs HH445-R1.

    Recall: Z-1456-06 · Initiated June 12, 2006

    Recall

    Recall Number
    Z-1456-06
    Event Number
    35497
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CCH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 12, 2006
    Posted
    August 30, 2006
    Terminated
    November 19, 2007
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catalogs HH445-R1.

    Reason

    Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

    Action

    Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.

    Distribution

    Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela.

    Quantity

    To be determined