{
  "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": "69094",
      "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": "Letter",
      "distribution_pattern": "Distributed USA (nationwide) and in Singapore.",
      "recall_number": "Z-0007-2015",
      "product_description": "VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD.    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": "Domestic: 339 sales units; Foreign: 10 sales units",
      "reason_for_recall": "Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913.  Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution.  Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.",
      "recall_initiation_date": "20140820",
      "center_classification_date": "20141002",
      "termination_date": "20170411",
      "report_date": "20141008",
      "code_info": "Lot Number 2613-0150-4913, exp. 15-Nov-2014"
    }
  ]
}