BEUDAMED
    FDA Recall Terminated

    The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

    Recall: Z-2649-2017 · Initiated November 22, 2010

    Recall

    Recall Number
    Z-2649-2017
    Event Number
    77453
    Firm
    Medtest Holdings, Inc.
    FEI Number
    1827821
    Product Code
    JHW
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 22, 2010
    Posted
    June 29, 2017
    Terminated
    July 24, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

    Reason

    Incorrect control range in product labeling

    Action

    On 11/22/2010, TECHNICAL BULLETIN notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.

    Distribution

    FL, AR, NICARAGUA, KOREA

    Quantity

    5 kits