Device recall
Z-2049-2017: Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular…
FDA device recall · Class II · Roche Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-2049-2017 |
|---|---|
| Recall event | 76854 |
| Product | Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric… |
| Product code | JJE |
| Recalling firm | Roche Diagnostics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 2, 2017 |
| 510(k) numbers | K060373, K100853 |
| 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