Recall Z-0996-04 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Roche Diagnostics Corp.
Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
| Date | Jul 20, 2004 (initiated Mar 5, 2004) |
| Status | Terminated |
| Reason | If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches. |
| Root cause | Other |
| Action | Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04. |
| Quantity | 14 |
| Distribution | Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953345 | GENESIS Tecan U.S., Inc., Nov 21, 1995 |