Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution
LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls must score at least 4. No illnesses or injuries have been reported, supporting a Severe (rather than Critical) classification.
Plain-English summary
The Leccurate SARS-CoV-2 Antibody Rapid Test Kit, manufactured by LEPU Medical Technology (Beijing) Co., Ltd., is a diagnostic test designed to detect IgM and/or IgG antibodies to SARS-CoV-2 in serum, plasma, or venipuncture whole blood samples. The test uses colloidal gold immunochromatography technology.
The FDA has determined that this test is not authorized, cleared, or approved for marketing and/or distribution in the United States. The device does not meet U.S. requirements for proper medical device authorization.
Approximately 8.4 million units have been distributed worldwide, including to U.S. locations in Florida, Illinois, New York, Georgia, and Puerto Rico, as well as internationally to Canada, Honduras, Peru, Dominican Republic, Bolivia, Colombia, Mexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay, Panama, Costa Rica, and Hong Kong.
Patients and healthcare providers in the U.S. who possess this test should consult with their healthcare provider about appropriate COVID-19 testing alternatives. Healthcare facilities with this test in stock should discontinue use and contact the FDA for guidance on proper device handling and disposal.
The recalled product
- 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 adapti
- Manufacturer
- LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
- Category
- Medical Device — Diagnostic Test
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots distributed within the U.S.
Distribution
Part of a larger recall action
This product is one of 2 recalled by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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