Device recall
Z-0807-2018: VITROS Chemistry Products Performance Verifier is used as an assayed control to…
FDA device recall · Class III · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0807-2018 |
|---|---|
| Recall event | 78724 |
| Product | VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600… |
| Product code | JJY |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 6, 2020 |
| 510(k) numbers | K042006 |
| 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