{
  "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": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "100 Indigo Creek Dr",
      "reason_for_recall": "Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.",
      "address_2": "",
      "product_quantity": "339 Total: USA - 102, Foreign - 237",
      "code_info": "Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)",
      "center_classification_date": "20150114",
      "distribution_pattern": "Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.",
      "state": "NY",
      "product_description": "VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics.    The VITROS 4600 Chemistry System is intended 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).",
      "report_date": "20150121",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-0968-2015",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "69830",
      "termination_date": "20180521",
      "more_code_info": "",
      "recall_initiation_date": "20141119",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}