BEUDAMED
    FDA Recall 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 · Initiated December 12, 2014

    Recall

    Recall Number
    Z-2773-2015
    Event Number
    71974
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CGX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 12, 2014
    Posted
    September 16, 2015
    Terminated
    October 29, 2015
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    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.

    Action

    On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313.

    Distribution

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

    Quantity

    93 kits