BEUDAMED
    FDA Recall Terminated

    STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.

    Recall: Z-0039-2008 · Initiated July 30, 2007

    Recall

    Recall Number
    Z-0039-2008
    Event Number
    39419
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GKP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 30, 2007
    Posted
    October 11, 2007
    Terminated
    December 17, 2007
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.

    Reason

    Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

    Action

    Recall notification letters were mailed to consignees on 7/30/07 by first class mail.

    Distribution

    Nationwide.

    Quantity

    41 units installed