Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
FDA device recall Z-0869-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- Tecan U S Inc
- Reason for recall
- Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQW
- Quantity affected
- 327 instruments require firmware upgrade.
- Distribution
- Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
- Date initiated
- 2003-02-27
- Date posted
- 2003-05-29
- Date terminated
- 2006-04-06
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENESIS (K953345) | Tecan U.S., Inc. | 1995-11-21 |