BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.

    Recall: Z-1431-04 · Initiated August 6, 2004

    Recall

    Recall Number
    Z-1431-04
    Event Number
    29648
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 6, 2004
    Posted
    September 2, 2004
    Terminated
    June 26, 2006
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.

    Reason

    A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

    Action

    Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.

    Distribution

    United States.