BEUDAMED
    FDA Recall Terminated

    Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.

    Recall: Z-0328-04 · Initiated December 15, 2003

    Recall

    Recall Number
    Z-0328-04
    Event Number
    27922
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2003
    Posted
    January 10, 2004
    Terminated
    August 2, 2004
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.

    Reason

    If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

    Action

    Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.

    Distribution

    United States.