FDA Medical Device Recalls (openFDA)
Tecan U S Inc: Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
- Recall number
- Z-0869-03
- Recalling firm
- Tecan U S Inc
- Product
- Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
- Status
- Terminated
- Initiated
- 2003-02-27
- Posted
- 2003-05-29
- Terminated
- 2006-04-06
- 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 .
- Lot, serial or model codes
- Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower
- 510(k) numbers
- ["K953345"]
- PMA numbers
- not on file
- Product code
- JQW
- Firm FEI
- 1037985
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28