BEUDAMED
    FDA Recall Terminated

    Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.

    Recall: Z-0996-04 · Initiated March 5, 2004

    Recall

    Recall Number
    Z-0996-04
    Event Number
    28984
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 5, 2004
    Posted
    July 20, 2004
    Terminated
    August 7, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.

    Reason

    If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.

    Action

    Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.

    Distribution

    Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.

    Quantity

    14