{
  "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": "65207",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Dr",
      "address_2": "N/A",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide including the states of  AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of:  Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain",
      "recall_number": "Z-1648-2013",
      "product_description": "VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445)     Product Usage:  For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)",
      "product_quantity": "Total 69 units (28 units domestically and 41 units internationally)",
      "reason_for_recall": "There is evidence that an electrical short within the systems connector has caused an accumulation of  heat which has radiated back through the wiring harness causing the wires and connectors to melt.",
      "recall_initiation_date": "20130506",
      "center_classification_date": "20130701",
      "termination_date": "20180516",
      "report_date": "20130710",
      "code_info": "Serial numbers:  J46000021, J46000110 through J46000177"
    }
  ]
}