Class 2 Device Recall OMNI

• Date Initiated by Firm: December 09, 2005
• Date Posted: January 07, 2006
• Recall Status: Terminated on April 10, 2006
• Recall Number: Z-0361-06
• Recall Event ID: 34180
• Product Classification: Whole Blood Hemoglobin Determination - Product Code KHG
• Product: Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
• Code Information: All units with Co-Oximetry (COOX) modules.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-526-2272
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter dated 12/9/05.
• Distribution: California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.