Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001.
This recall has been terminated (originally issued January 7, 2006).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- December 9, 2005
- Posted
- January 7, 2006
- Terminated
- April 10, 2006
- Recall Number
- Z-0362-06
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.
Lot / Code Info
All units with Co-Oximetry (COOX) modules.
Root Cause
Other
Action Taken
Consignees were notified via letter dated 12/9/05.
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