Device recall
Z-0120-2022: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls…
FDA device recall · Class II · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0120-2022 |
|---|---|
| Recall event | 88737 |
| Product | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG… |
| Product code | QKO |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2024 |
| FEI number | 2250051 |
At a glance
- None 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