Device recall
Z-0450-2021: VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage…
FDA device recall · Class II · Ortho Clinical Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0450-2021 |
|---|---|
| Recall event | 86573 |
| Product | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product… |
| Product code | QMN |
| Recalling firm | Ortho Clinical Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2023 |
| FEI number | 2250051 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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