Recall Z-1001-04 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Roche Diagnostics Corp.
Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
| Date | Jul 20, 2004 (initiated May 5, 2004) |
| Status | Terminated |
| Reason | Tecan software has the potential to match the patient with a different patient's test results. |
| Root cause | Other |
| Action | Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories. |
| Quantity | 8 |
| Distribution | Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, Texas and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.