Device recall
Z-1619-2021: Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold…
FDA device recall · Class I · LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Key facts
| Recall number (Z-number) | Z-1619-2021 |
|---|---|
| Recall event | 87737 |
| Product | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to… |
| Product code | QKO |
| 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