Recall Z-0361-06 ยท KHG Whole Blood Hemoglobin Determination
Roche Diagnostics Corp.
Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
| Date | Jan 7, 2006 (initiated Dec 9, 2005) |
| Status | Terminated |
| 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. |
| Distribution | California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.