The Recall Desk

FDA (Devices) recall action 87737

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD recalled 2 products on 2021-06-09

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-06-09
Critical
0
Units
—

Why these products were recalled

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

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2021-06-09

    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.

    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).
    Category
    Distribution
    5 states
  • SevereFDA (Devices)··2021-06-09

    Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution

    LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.

    Product
    Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an…
    Category
    Distribution
    5 states