{
  "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": "If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?.¿ The difference in terminology exists for US Markets only.",
      "address_2": "",
      "product_quantity": "US: 30 units",
      "code_info": "Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; Serial Numbers/J Numbers: JIM341866, JIM341820, JIM341679, JIM341352, JIM343421, JIM341174, JIM336745, JIM340667, JIM338283,   JIM-341592, JIM336957, JIM341996, JIM342334, JIM343694, JIM336855,   JIM334236, JIM341415, JIM341392, JIM336481, JIM340934, JIM336167,   JIM342249, JIM338290, JIM341750, JIM341426, JIM334986, JIM334527,   JIM340024, JIM341021, JIM340658",
      "center_classification_date": "20160708",
      "distribution_pattern": "Nationwide",
      "state": "NY",
      "product_description": "enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD",
      "report_date": "20160720",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-2143-2016",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "74354",
      "termination_date": "20180608",
      "more_code_info": "",
      "recall_initiation_date": "20160516",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}