Device recall
Z-0716-2022: LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat…
FDA device recall · Class I · Lusys Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0716-2022 |
|---|---|
| Recall event | 89539 |
| Product | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) |
| Product code | QKP |
| Recalling firm | Lusys Laboratories, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3004473533 |
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