FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
- Recall number
- Z-0361-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
- Status
- Terminated
- Initiated
- 2005-12-09
- Posted
- 2006-01-07
- Terminated
- 2006-04-10
- Reason
- Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.
- Root cause
- Other
- Action
- Consignees were notified via letter dated 12/9/05.
- Quantity
- not on file
- Distribution
- California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.
- Lot, serial or model codes
- All units with Co-Oximetry (COOX) modules.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KHG
- 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