FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
- Recall number
- Z-0326-04
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
- Status
- Terminated
- Initiated
- 2003-12-15
- Posted
- 2004-01-10
- Terminated
- 2004-08-02
- Reason
- If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
- Root cause
- Other
- Action
- Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.
- Quantity
- not on file
- Distribution
- United States.
- Lot, serial or model codes
- All units with software version 5.61 or below.
- 510(k) numbers
- ["K972733"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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