BEUDAMED
    FDA Recall Terminated

    Roche Cobas driver (rchcob6i), analytical laboratory data interface.

    Recall: Z-0224-2007 · Initiated November 3, 2006

    Recall

    Recall Number
    Z-0224-2007
    Event Number
    36752
    Firm
    Data Innovations, Inc.
    FEI Number
    3001451449
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    November 3, 2006
    Posted
    November 29, 2006
    Terminated
    June 11, 2015
    Address
    120 Kimball Ave, Ste 100, South Burlington, VT, 05403-6837

    Description

    Roche Cobas driver (rchcob6i), analytical laboratory data interface.

    Reason

    Software of modular driver may incorrectly report patient results as Quality Control Results

    Action

    Data Innovations notified users by email listserv and by letter dated 10/25/06.

    Distribution

    Nationwide and Canada.

    Quantity

    56