Device recall
Z-1005-2025: Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog…
FDA device recall · Class II · Ortho-Clinical Diagnostics, INc.
Key facts
| Recall number (Z-number) | Z-1005-2025 |
|---|---|
| Recall event | 96031 |
| Product | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No… |
| Product code | JJE |
| Recalling firm | Ortho-Clinical Diagnostics, INc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K081543 |
| FEI number | 1000305840 |
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