{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "114109",
      "product_res_number": "Z-0490-2013",
      "event_date_initiated": "2012-07-16",
      "event_date_posted": "2012-12-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-07-22",
      "res_event_number": "63312",
      "product_code": "NSX",
      "product_description": "The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.",
      "code_info": "Device-associated diagnostic software",
      "firm_fei_number": "2243471",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 Us Highway 202 S 1080 Us Highway 202",
      "city": "S Branchburg",
      "state": "NJ",
      "postal_code": "08876-3733",
      "additional_info_contact": "Mr. Vincent Stagnitto\n908-253-7569",
      "reason_for_recall": "Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.",
      "root_cause_description": "Software design",
      "action": "Roche sent an \"Urgent Medical Device Correction\" (UMDC) notification letter dated July 16, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software.  Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number :  1-800-428-2336 if you have questions regarding this notification. \nFor questions regarding this recall call 908-253-7569.",
      "product_quantity": "855 units.",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "registration_number": [
          "3031158",
          "3003587684",
          "3003971136",
          "1528142",
          "9611031",
          "9611109",
          "2024500"
        ],
        "fei_number": [
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          "3003587684",
          "1000122772",
          "3002808267",
          "3002807019",
          "3003971136",
          "3000215024"
        ]
      }
    }
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}