Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Leccurate SARS-CoV-2 Recalled by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Due to Antigen Rapid Test Kit is not authorized, cleared,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD directly.
Affected Products
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).
Quantity: 8, 419, 545 units in total
Why Was This Recalled?
Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Where Was This Sold?
This product was distributed to 4 states: FL, GA, IL, NY
About LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report