Device recall
Z-2557-2018: cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product…
FDA device recall · Class II · Roche Diagnostics Hematology
Key facts
| Recall number (Z-number) | Z-2557-2018 |
|---|---|
| Recall event | 80376 |
| Product | cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The… |
| Product code | JOY |
| Recalling firm | Roche Diagnostics Hematology |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| 510(k) numbers | K171655 |
| FEI number | 3012792398 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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