FDAApril 26, 2021device

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).

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Completed

Brands named

lepu medical technology beijinglepulepu medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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