Device recall
Z-1432-2021: Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep…
FDA device recall · Class II · AZURE BIOTECH INC
Key facts
| Recall number (Z-number) | Z-1432-2021 |
|---|---|
| Recall event | 87541 |
| Product | Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM… |
| Product code | QKO |
| Recalling firm | AZURE BIOTECH INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2023 |
| FEI number | 3014862351 |
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