BEUDAMED
    FDA Enforcement Class III Terminated

    Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.

    Recall: Z-2773-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2773-2015
    Event ID
    71974
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pointe Scientific, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 23, 2015
    Initiation Date
    December 12, 2014
    Classification Date
    September 16, 2015
    Termination Date
    October 29, 2015
    Address
    5449 Research Dr, Canton, MI, 48188-2261, United States

    Description

    Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.

    Reason

    Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.

    Code Info

    C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03

    Distribution

    Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.

    Quantity

    93 kits