Device recall
Z-2408-2021: FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and…
FDA device recall · Class II · Versea Diagnostics LLC
Key facts
| Recall number (Z-number) | Z-2408-2021 |
|---|---|
| Recall event | 88429 |
| Product | FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive… |
| Product code | QKO |
| Recalling firm | Versea Diagnostics LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2024 |
| FEI number | 3019891938 |
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