Device recall
Z-2878-2020: VITROS XT3400 Chemistry System, Product code 6844458
FDA device recall · Class II · Ortho Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-2878-2020 |
|---|---|
| Recall event | 86096 |
| Product | VITROS XT3400 Chemistry System, Product code 6844458 |
| Product code | JJE |
| Recalling firm | Ortho Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 18, 2023 |
| 510(k) numbers | K182063 |
| FEI number | 1000136573 |
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