{
  "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": [
    {
      "country": "United States",
      "city": "Raritan",
      "address_1": "1001 US Highway 202",
      "reason_for_recall": "The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.",
      "address_2": "",
      "product_quantity": "68230",
      "code_info": "5535  5540  5550  5560  5570  5580  5590  5600  5610  5615  5620  5630  5640  5650  5655  5660  5665  5670  5675  5678  5680  5685  5690",
      "center_classification_date": "20181003",
      "distribution_pattern": "Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.",
      "state": "NJ",
      "product_description": "VITROS Immunodiagnostic Products - TSH Reagent Pack  (10758750000227) 1912997",
      "report_date": "20181010",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho Clinical Diagnostics Inc",
      "recall_number": "Z-0061-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80717",
      "more_code_info": "",
      "recall_initiation_date": "20180712",
      "postal_code": "08869-1424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}