medical Class I Updated 2021-06-09

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD recalls Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold

Recalled 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).

Hazard / Issue

Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Issued by

FDA

Affected States: FL, IL, NY, GA
Lot/Code Info: All Lots distributed within the U.S.
View official government recall

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