BEUDAMED
    FDA Recall Terminated

    Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    Recall: Z-1368-2013 · Initiated April 4, 2013

    Recall

    Recall Number
    Z-1368-2013
    Event Number
    64850
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 4, 2013
    Posted
    May 23, 2013
    Terminated
    February 24, 2015
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    Reason

    When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluent

    Action

    Roche sent an Urgent Medical Device Correction (UMDC) letter dated April 4, 2013 via UPS to all affected customers. The letter idenified the affected product, problem and instruction to be followed. Customers were instructed to consult with the physician or pathologist at their facility to determine specific clinical implications for patients. A future software version will correct this issue. Customers were asked to complete and fax back the UMDC attached fax form to 1-88-628-0730. Questions should be addresssed to Roche Diagnostics Technical Support 24 hours a day at 1-800-428-2336.

    Distribution

    USA Nationwide Distribution

    Quantity

    72 units