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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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.
See all 2 products in this recall →Related recalls
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