BEUDAMED
    FDA Recall Terminated

    NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).

    Recall: Z-0735-04 · Initiated February 26, 2004

    Recall

    Recall Number
    Z-0735-04
    Event Number
    28435
    Firm
    Biomerieux, Inc.
    FEI Number
    1039284
    Product Code
    JJQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 26, 2004
    Posted
    July 20, 2004
    Terminated
    March 24, 2004
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    NucliSensEasy Q Incubator, Product Number 285204 (this number can be found at the back of the instrument).

    Reason

    Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard.

    Action

    This correction is being handled as an instrument repair (rework) by bioMerieux Field Service; therefore no communication has been sent to the customer sites. The repair involves heat sink replacement or use of insulating tape on the rear side of the keypad.

    Distribution

    CT, MD, MT

    Quantity

    3 units