BEUDAMED
    FDA Enforcement Class III Terminated

    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.

    Recall: Z-2764-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2764-2015
    Event ID
    71953
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pointe Scientific, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 23, 2015
    Initiation Date
    March 13, 2015
    Classification Date
    September 16, 2015
    Termination Date
    October 29, 2015
    Address
    5449 Research Dr, Canton, MI, 48188-2261, United States

    Description

    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.

    Reason

    Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.

    Code Info

    Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402

    Distribution

    Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.

    Quantity

    H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits