BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.

    Recall: Z-0165-2009 · Initiated June 24, 2008

    Recall

    Recall Number
    Z-0165-2009
    Event Number
    48711
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2008
    Posted
    October 22, 2008
    Terminated
    October 22, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.

    Reason

    A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.

    Action

    The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.

    Distribution

    Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.