BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250

    Recall: Z-0867-2008 · Initiated March 21, 2008

    Recall

    Recall Number
    Z-0867-2008
    Event Number
    47371
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    March 21, 2008
    Posted
    August 13, 2008
    Terminated
    November 18, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250

    Reason

    Possible mismatch between patient and result.

    Action

    Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.

    Distribution

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

    Quantity

    11 of all models