Device recall
Z-0471-2021: VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use…
FDA device recall · Class III · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0471-2021 |
|---|---|
| Recall event | 86669 |
| Product | VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code… |
| Product code | JJY |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K904768 |
| FEI number | 2250051 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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