{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77613",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "513 Technology Blvd",
      "address_2": "N/A",
      "postal_code": "14626-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution -  US Distribution including  Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.",
      "recall_number": "Z-0273-2018",
      "product_description": "VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc.    For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.",
      "product_quantity": "US; 4680; Foreign: 1286",
      "reason_for_recall": "The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples.  The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.",
      "recall_initiation_date": "20170612",
      "center_classification_date": "20171222",
      "termination_date": "20200811",
      "report_date": "20180103",
      "code_info": "Unique Identifier Number ( UDI)  10758750004690; This issue affects expired, current (in date) and future product GENs."
    }
  ]
}