RegWardenFDA facility compliance records
Company

Lepu Medical Technology (Beijing) Co., Ltd

1 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2021: 1 recalls20172018201920201202120222023202420252026
  • Recalls (1)

Registered facilities (3)

Recalls & enforcement

  • Class ICompleted2021-04-26
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Lepu Medical Technology (Beijing) Co., Ltd — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10038811-lepu-medical-technology-beijing-co-ltd/

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