Device recall
Z-1688-2021: VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a…
FDA device recall · Class II · Ortho-Clinical Diagnostics, INc.
Key facts
| Recall number (Z-number) | Z-1688-2021 |
|---|---|
| Recall event | 87888 |
| Product | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM. |
| Product code | QKP |
| Recalling firm | Ortho-Clinical Diagnostics, INc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2023 |
| FEI number | 1000305840 |
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