Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution
The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.
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: This FDA Class I recall of an unauthorized SARS-CoV-2 diagnostic device requires a minimum severity score of 4 per the recall severity rubric. Although no illnesses or injuries have been reported, an unapproved diagnostic test poses a significant public health risk.
Plain-English summary
The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is a medical device manufactured by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. designed to detect SARS-CoV-2 antigen in nasal swab samples. The FDA recalled this device because it was not authorized, cleared, or approved for marketing and distribution in the United States.
Approximately 8.4 million units were distributed worldwide. Within the United States, distribution occurred in Florida, Illinois, New York, Georgia, and Puerto Rico. The device was also distributed to multiple countries including Canada, Honduras, Peru, Dominican Republic, Bolivia, Colombia, Mexico, Brazil, Argentina, Guatemala, Venezuela, Ecuador, Chile, Paraguay, Panama, Costa Rica, and Hong Kong.
This is classified as an FDA Class I recall, reflecting the agency's determination that the unauthorized device poses a potential health risk.
The recalled product
- Product
- 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).
- Manufacturer
- LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
- Hazard
- unauthorized-device
- diagnostic-unreliability
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
Distributed in 4 states:
- FL
- GA
- IL
- NY
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