{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91205",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "100 Indigo Creek Dr",
      "address_2": "N/A",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia,  Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia,  Singapore, Spain, Sweden, The Netherlands, United Kingdom.",
      "recall_number": "Z-0878-2023",
      "product_description": "VITROS Immunodiagnostic Products Intact PTH Reagent Pack-  IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin)  Catalog Number: 6802892",
      "product_quantity": "4,158 units",
      "reason_for_recall": "Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results",
      "recall_initiation_date": "20221117",
      "center_classification_date": "20230104",
      "report_date": "20230111",
      "code_info": "UDI-DI: 6802892 (10758750006267) Lot Numbers/Exp Date: 1610    24-Apr-2023; 1621    24-Apr-2023; 1630    08-May-2023; 1640    08-May-2023; 1645    08-May-2023; 1650    29-May-2023; 1670    06-Jun-2023"
    }
  ]
}