Leccurate SARS-CoV-2 — Class I medical device recall Z-1619-2021
Completed recall by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD, reported 2021-06-09, distributed in FL, GA, IL, NY, PR. Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared
| Recall number | Z-1619-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD, Beijing, China |
| Recall initiated | 2021-04-26 |
| Classified | 2021-05-28 |
| Reported by FDA | 2021-06-09 |
| Distributed | FL, GA, IL, NY, PR |
| Countries outside the US | AR, BO, BR, CA, CL, CO, CR, EC, GT, HK, HN, MX, PA, PE, PY, VE |
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 SARS-CoV-2, indicating recent or prior infection.
Reason for recall
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1619-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.