{
  "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-0450-2021",
      "product_description": "VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories--   Product Code (Unique Identifier): 6199920  (10758750033362)",
      "product_quantity": "651 units",
      "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:  0165   24-NOV-20  0180   19-NOV-20  0185   27-NOV-20  0190   21-NOV-20  0200   23-NOV-20  0205   27-NOV-20  0220   03-DEC-20  0230   03-DEC-20"
    }
  ]
}