{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Beijing",
      "state": "",
      "country": "China",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87737",
      "recalling_firm": "LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD",
      "address_1": "Building 7-1",
      "address_2": "NO. 37 Chaoqian Rd; Changping Tech Zone",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "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.",
      "recall_number": "Z-1619-2021",
      "product_description": "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 adaptive immune response to SARS-CoV-2, indicating recent or prior infection.",
      "product_quantity": "8, 419, 545 units in total",
      "reason_for_recall": "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.",
      "recall_initiation_date": "20210426",
      "center_classification_date": "20210528",
      "report_date": "20210609",
      "code_info": "All Lots distributed within the U.S.",
      "more_code_info": ""
    }
  ]
}