Roche Diagnostics Operations, Inc. Recall: Omni Micro-electrode/reference electrode for co
Roche Diagnostics Operations, Inc. Recall: Omni Micro-electrode/reference electrode for co is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Diagnostics Operations, Inc.; Product: Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 031118731
| Recalling firm | Roche Diagnostics Operations, Inc. |
|---|---|
| Product | Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen satu |
| Reason for recall | Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA nationwide including PR and the country of Guam. |
| Recall initiated | 20140228 |
| Recall number | Z-1315-2014 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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