Device recall
Z-0064-2015: Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche…
FDA device recall · Class III · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-0064-2015 |
|---|---|
| Recall event | 69173 |
| Product | Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total… |
| Product code | CHL |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 10, 2018 |
| 510(k) numbers | K032311 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database