BEUDAMED
    FDA Recall Terminated

    Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.

    Recall: Z-0999-04 · Initiated May 5, 2004

    Recall

    Recall Number
    Z-0999-04
    Event Number
    29060
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2004
    Posted
    July 20, 2004
    Terminated
    July 24, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.

    Reason

    Tecan software has the potential to match the patient with a different patient's test results.

    Action

    Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories.

    Distribution

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

    Quantity

    11