Device recall
Z-1396-2023: VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators…
FDA device recall · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1396-2023 |
|---|---|
| Recall event | 92017 |
| Product | VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976 |
| Product code | QKO |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 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