Device recall
Z-2136-2018: cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a…
FDA device recall · Class II · Roche Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-2136-2018 |
|---|---|
| Recall event | 79805 |
| Product | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal… |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2019 |
| 510(k) numbers | K100853, K162606, K163569 |
| 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