{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bethlehem",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73643",
      "recalling_firm": "OraSure Technologies, Inc.",
      "address_1": "1745 Eaton Ave",
      "address_2": "N/A",
      "postal_code": "18018-1769",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.",
      "recall_number": "Z-1509-2016",
      "product_description": "OraQuick HCV Visual Reference Panel     Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.",
      "product_quantity": "244 Visual Reference Panel Kits",
      "reason_for_recall": "OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.",
      "recall_initiation_date": "20160115",
      "center_classification_date": "20160418",
      "termination_date": "20180207",
      "report_date": "20160427",
      "code_info": "Item Number 1001-0343, Lot # 6648737"
    }
  ]
}