FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.
- Recall number
- Z-1021-04
- Recalling firm
- Roche Diagnostics Corp.
- Product
- COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001.
- Status
- Terminated
- Initiated
- 2004-05-05
- Posted
- 2004-07-20
- Terminated
- 2007-07-24
- Reason
- The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
- Root cause
- Other
- Action
- Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to each user consignee.
- Quantity
- 8
- Distribution
- California, Connecticut, Illinois, Massachusetts Pennsylvania, Texas and Wisconsin.
- Lot, serial or model codes
- All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768 .
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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