Device recall
Z-0718-2022: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies…
FDA device recall · Class I · Lusys Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0718-2022 |
|---|---|
| Recall event | 89539 |
| Product | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111 |
| Product code | QKO |
| 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