Device recall
Z-2771-2020: VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number…
FDA device recall · Class II · Ortho Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-2771-2020 |
|---|---|
| Recall event | 86038 |
| Product | VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only. |
| Product code | QKO |
| Recalling firm | Ortho Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2021 |
| 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