{
  "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": "2026-07-08",
    "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": "95020",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "100 Indigo Creek Dr",
      "address_2": "",
      "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, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Sweden, United Kingdom.",
      "recall_number": "Z-2580-2024",
      "product_description": "VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2",
      "product_quantity": "18,467 units",
      "reason_for_recall": "It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in \"TM5-4MB\" condition codes which lead to a delay of results.",
      "recall_initiation_date": "20240703",
      "center_classification_date": "20240812",
      "report_date": "20240821",
      "code_info": "Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.",
      "more_code_info": ""
    }
  ]
}