{
  "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": "Terminated",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87263",
      "recalling_firm": "Confirm Biosciences Inc",
      "address_1": "10123 Carroll Canyon Rd",
      "address_2": "N/A",
      "postal_code": "92131-1109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of  Australia, Mexico, Honduras, Spain, Sierra Leone, Bahamas, Ecuador, Turkey, Romania, Kuwait, Libya, Qatar, Ghana, Argentina, Bolivia, Brazil, Guatemala, Panama, India, United Kingdom, West Indies, South Africa, United Arab Emirates, Slovenia, Canada, Israel, United Kingdom, Romania, Argentina,  Honduras, Russian Federation, R¿publique D¿mocratique du Congo, Switzerland, Dominican Republic, Greece, Saudi Arabia, and Portugal.",
      "recall_number": "Z-1125-2021",
      "product_description": "Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.",
      "product_quantity": "563,840 cassettes",
      "reason_for_recall": "Due to two (2) issues:  1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories.  2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).",
      "recall_initiation_date": "20210129",
      "center_classification_date": "20210216",
      "termination_date": "20221213",
      "report_date": "20210224",
      "code_info": "Catalog Number: HE Cassette COVID 19EUA  Lot Numbers:  2006167eua  2006168eua  2006169eua"
    }
  ]
}