Device recall
Z-1620-2021: Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold…
FDA device recall · Class I · LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Key facts
| Recall number (Z-number) | Z-1620-2021 |
|---|---|
| Recall event | 87737 |
| Product | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab). |
| Product code | QKP |
| Recalling firm | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
| Recall class | Class I |
| Status | Completed |
| FEI number | 3008002401 |
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