{
  "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": "88737",
      "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) in states of: AL, AR, AZ, CA, CO, DC, FL, ID, KS, KY, LA, ME, MI, MS, MO, NY, TN, TX and WV; and OUS (Foreign) in countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico,\tSingapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark,\tNorway, Sweden, Belgium, and The Netherlands.",
      "recall_number": "Z-0120-2022",
      "product_description": "VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)-  For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2.  Product Code: 6199966",
      "product_quantity": "US: 64 OUS: 200",
      "reason_for_recall": "VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results",
      "recall_initiation_date": "20210910",
      "center_classification_date": "20211015",
      "termination_date": "20240213",
      "report_date": "20211027",
      "code_info": "Lot Number: 0040(*and potentially future lots)  UDI: 10758750034475  Exp. Date: 19NOV2021"
    }
  ]
}