Device recall
Z-2143-2016: enGen Laboratory Automation System, Product Code engen, Software Versions enGen…
FDA device recall · Class III · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-2143-2016 |
|---|---|
| Recall event | 74354 |
| Product | enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD |
| Product code | JJE |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 8, 2018 |
| 510(k) numbers | K063144 |
| 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