FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
- Recall number
- Z-0996-04
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
- Status
- Terminated
- Initiated
- 2004-03-05
- Posted
- 2004-07-20
- Terminated
- 2007-08-07
- Reason
- If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.
- Root cause
- Other
- Action
- Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.
- Quantity
- 14
- Distribution
- Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
- Lot, serial or model codes
- Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.
- 510(k) numbers
- ["K953345"]
- PMA numbers
- not on file
- Product code
- JQW
- 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