Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001.
FDA device recall Z-0362-06 · posted 2006-01-07 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- 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.
- Action taken
- Consignees were notified via letter dated 12/9/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Distribution
- California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.
- Date initiated
- 2005-12-09
- Date posted
- 2006-01-07
- Date terminated
- 2006-04-10
- Location
- Indianapolis, IN
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