Device recall
Z-1058-2022: ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried…
FDA device recall · Class II · PROTERIXBIO
Key facts
| Recall number (Z-number) | Z-1058-2022 |
|---|---|
| Recall event | 90107 |
| Product | ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number |
| Product code | QKO |
| Recalling firm | PROTERIXBIO |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 23, 2024 |
| FEI number | 3012671593 |
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