FDA Medical Device Recalls (openFDA)
Tecan U S Inc: Tecan Clinical Workstations with Robonet software
- Recall number
- Z-1022-04
- Recalling firm
- Tecan U S Inc
- Product
- Tecan Clinical Workstations with Robonet software
- Status
- Terminated
- Initiated
- 2004-05-03
- Posted
- 2004-07-20
- Terminated
- 2005-05-17
- 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.
- Lot, serial or model codes
- PN 10-410 Tecan Genesis 150/8 Back End Configuration, PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
- 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