Device recall
Z-1267-2021: VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products…
FDA device recall · Class II · Ortho-Clinical Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1267-2021 |
|---|---|
| Recall event | 87356 |
| Product | VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2… |
| Product code | QKP |
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 24, 2022 |
| FEI number | 1000136573 |
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