{
  "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": [
    {
      "country": "United States",
      "city": "San Diego",
      "address_1": "7110 Carroll Rd",
      "reason_for_recall": "The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.",
      "address_2": "",
      "product_quantity": "2886",
      "code_info": "Lot Numbers: P826, P815, P796, P776",
      "center_classification_date": "20201106",
      "distribution_pattern": "U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.",
      "state": "CA",
      "product_description": "EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032     Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.",
      "report_date": "20201118",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Epitope Diagnostics, Inc.",
      "recall_number": "Z-0426-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "86516",
      "more_code_info": "",
      "recall_initiation_date": "20201001",
      "postal_code": "92121-2215",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}