BEUDAMED
    FDA Recall Terminated

    STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France

    Recall: Z-0812-2007 · Initiated January 18, 2007

    Recall

    Recall Number
    Z-0812-2007
    Event Number
    37868
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GKP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 18, 2007
    Posted
    May 16, 2007
    Terminated
    December 10, 2007
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France

    Reason

    Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

    Action

    A recall notification has not been sent. The firm did issue a technical bulletin to their representatives.--Update: based on FDA input the firm issued a Recall Letter to all users dated May 25, 2007

    Distribution

    Product was distributed to hospitals and laboratories nationwide.

    Quantity

    693 units