{
  "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": "2026-04-15",
    "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": "76119",
      "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": "Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.",
      "recall_number": "Z-1117-2017",
      "product_description": "VITROS Na+ Slides, (UPN 10758750004812)    For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.",
      "product_quantity": "659,957 Total Units (249,570 units domestically & 410,387 units internationally)",
      "reason_for_recall": "There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU.  If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.",
      "recall_initiation_date": "20161220",
      "center_classification_date": "20170131",
      "termination_date": "20180622",
      "report_date": "20170208",
      "code_info": "Generation (GEN): 1 through 6, 30 through 40, 44 through 49  Expiry Dates: 01-JAN-2017 through 01-JUN-2018",
      "more_code_info": ""
    }
  ]
}