FDA Device

Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.

Hazard

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.

What You Should Do

Remedy

Consignees were notified via letter dated 12/9/05.

Products

Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
Brand
Roche Diagnostics Corp.
UPC
All units with Co-Oximetry (COOX) modules.