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).
Reported: June 9, 2021 Initiated: April 26, 2021 #Z-1620-2021
Product Description
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).
Reason for Recall
Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Details
- Recalling Firm
- LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
- Units Affected
- 8, 419, 545 units in total
- 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.
- Location
- Beijing
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. Units affected: 8, 419, 545 units in total.
Why was this product recalled? ▼
Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 9, 2021. Severity: Critical. Recall number: Z-1620-2021.
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