{
  "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": "Raritan",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86573",
      "recalling_firm": "Ortho Clinical Diagnostics Inc",
      "address_1": "1001 US Highway 202",
      "address_2": "N/A",
      "postal_code": "08869-1424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India,   Japan, Singapore 609917, United Kingdom, Italy.",
      "recall_number": "Z-0451-2021",
      "product_description": "VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2.    Product Code (Unique Identifier):   6199921 (10758750033355)",
      "product_quantity": "691 units (OUS)",
      "reason_for_recall": "Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control",
      "recall_initiation_date": "20200930",
      "center_classification_date": "20201113",
      "termination_date": "20231207",
      "report_date": "20201125",
      "code_info": "Lot Number/ Exp. Date:  0110  25-NOV-20"
    }
  ]
}