LEPU SARS-CoV-2 Antibody Test Kit Not Approved for U.S. Use
LEPU's SARS-CoV-2 antibody test kit is not approved for U.S. sale. This recall covers all units distributed in the U.S. due to lack of FDA authorization.
Recall notice
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.
Contact the company
What happened, in plain English
LEPU's SARS-CoV-2 antibody rapid test kit is being recalled because it has not been approved by the U.S. FDA for use in the United States. This means the product is not legally available for sale or use here. Read more at govinfonow.com/recall/62706-lepu-sars-cov-2-antibody-test-kit-not-approved-for.
Source Summary by GovInfoNow · govinfonow.com/recall/62706-lepu-sars-cov-2-antibody-test-kit-not-approved-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1619-2021
Cite this page
“LEPU SARS-CoV-2 Antibody Test Kit Not Approved for U.S. Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62706-lepu-sars-cov-2-antibody-test-kit-not-approved-for. Based on FDA recall #Z-1619-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1619-2021%22&limit=1).
Why it’s dangerous
The test kit has not been authorized, cleared, or approved by the U.S. Food and Drug Administration (FDA) for marketing or distribution in the United States. This means it does not meet U.S. safety and quality standards for medical devices.
Who’s affected
Anyone who purchased this test kit from a U.S. distributor. The risk is low since the product isn't approved for U.S. use, but users should avoid using it.
How to tell if you have this one
This product is labeled as 'Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD' and was distributed in the U.S. All units are affected.
- Brand
LEPU- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Completed- Distribution
Worldwide Distribution: US Distribution to states of: FL, IL, NY, GA, Puerto Rico and OUS countries of: Canada, Honduras, Peru, Dominican, Bolivia, Colombia, Mexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay, Panama, Costa Rica, Peru and Hong Kong.
| Recall number | Product, codes & lots |
|---|---|
| Z-1619-2021 | 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.; All Lots distributed within the U.S. |
| Z-1620-2021 | 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).; All Lots distributed within the U.S. |
What to do — step by step
Check Product Label
Look for the product name and model number on the label to confirm it matches the recalled item.
Where it went and when
Where it was distributed
Distributed in 4 states and Puerto Rico, and outside the U.S.
FDA distribution: “Worldwide Distribution: US Distribution to states of: FL, IL, NY, GA, Puerto Rico and OUS countries of: Canada, Honduras, Peru, Dominican, Bolivia, Colombia, Mexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Georgia, Illinois, New York, Puerto Rico.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this test kit?
Yes, because it is not approved for U.S. use and could pose risks if used incorrectly.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1619-2021 (April 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1619-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.