FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
- Recall number
- Z-0331-04
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
- Status
- Terminated
- Initiated
- 2003-12-29
- Posted
- 2004-07-20
- Terminated
- 2004-02-20
- Reason
- The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Root cause
- Other
- Action
- A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.
- Quantity
- not on file
- Distribution
- United States.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K945915","K954018"]
- PMA numbers
- not on file
- Product code
- JJE
- 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