Recall Z-1022-04 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Tecan U S Inc
Tecan Clinical Workstations with Robonet software
| Date | Jul 20, 2004 (initiated May 3, 2004) |
| Status | Terminated |
| Reason | Tecan software has the potential to match the patient with a different patient's test results. |
| Root cause | Other |
| Action | Consignees were notified by letter on May 3, 2004 |
| Quantity | 44 units (hardware), 33 units (software) |
| Distribution | CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953345 | GENESIS Tecan U.S., Inc., Nov 21, 1995 |