Device recall
Z-1315-2014: Omni Micro-electrode/reference electrode for cobas b221 analyzer…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1315-2014 |
|---|---|
| Recall event | 67549 |
| 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… |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| 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
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