Device recall
Z-0247-2022: VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For…
FDA device recall · Class III · Ortho-Clinical Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0247-2022 |
|---|---|
| Recall event | 88875 |
| Product | VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems |
| Product code | JJX |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 18, 2023 |
| 510(k) numbers | K032993 |
| FEI number | 1000136573 |
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