Device recall
Z-0847-2021: visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative…
FDA device recall · Class II · VISBY MEDICAL INC
Key facts
| Recall number (Z-number) | Z-0847-2021 |
|---|---|
| Recall event | 87049 |
| Product | visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization. |
| Product code | QJR |
| Recalling firm | VISBY MEDICAL INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2022 |
| FEI number | 3016608638 |
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