Recall Z-0869-03 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Tecan U S Inc
Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
| Date | May 29, 2003 (initiated Feb 27, 2003) |
| Status | Terminated |
| Reason | Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2. |
| Root cause | Other |
| Action | Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade. |
| Quantity | 327 instruments require firmware upgrade. |
| Distribution | Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953345 | GENESIS Tecan U.S., Inc., Nov 21, 1995 |