Device recall
Z-2481-2020: VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique…
FDA device recall · Class II · Ortho Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-2481-2020 |
|---|---|
| Recall event | 85762 |
| Product | VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103 |
| Product code | JJE |
| Recalling firm | Ortho Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2022 |
| 510(k) numbers | K083173 |
| 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