{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "175935",
      "product_res_number": "Z-2558-2019",
      "event_date_initiated": "2016-01-18",
      "event_date_created": "2019-09-23",
      "recall_status": "Open, Classified",
      "res_event_number": "83607",
      "product_code": "JJF",
      "k_numbers": [
        "K973628"
      ],
      "product_description": "V-Twin, Model # 6002-800, UDI: 03661540600180\n\nProduct Usage:\nAn in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.",
      "code_info": "Serial #s: 13-3341  and 13-3344",
      "firm_fei_number": "2708",
      "recalling_firm": "Vital Scientific N.V.",
      "address_1": "24, Kanaalweg 24 Kanaalweg",
      "address_2": "Postbus 100",
      "city": "Dieren",
      "country": "Netherlands",
      "reason_for_recall": "Instrument stopped working due to a software lockup, and no patient results are produced.",
      "root_cause_description": "Software Manufacturing/Software Deployment",
      "action": "In very close cooperation with the consignees, the affected end users running on EPROM version V1.2.3  were contacted. Initially,  a temporary work around (reset of the software) was communicated with the consignees.  The consignees devices were installed to document all errors during runtime .In addition, a new software was developed and tested. The new software resulted in version 1.2.5 of EPROM, which was released June 23, 2016. Consignees of the V-Twin all received a field update kit with the new software.",
      "product_quantity": "2",
      "distribution_pattern": "US in the state of New York.",
      "openfda": {
        "k_number": [
          "K971491",
          "K830095",
          "K871486",
          "K870777",
          "K903357",
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          "K883298",
          "K872120",
          "K802264",
          "K790335",
          "K844586",
          "K831227",
          "K850999",
          "K961209",
          "K973628",
          "K943978",
          "K964506",
          "K851172",
          "K790197",
          "K883020",
          "K833154",
          "K771939",
          "K965103",
          "K852385",
          "K012966",
          "K833804",
          "K033734",
          "K771821",
          "K820541",
          "K942676",
          "K802392",
          "K993634",
          "K863245",
          "K781606",
          "K833998",
          "K980056",
          "K052794",
          "K840200",
          "K851933",
          "K013654",
          "K864236",
          "K040332",
          "K851542",
          "K883350",
          "K893768",
          "K781442",
          "K864834",
          "K803004",
          "K821583",
          "K833153",
          "K964409",
          "K820415",
          "K802398",
          "K973177",
          "K771513"
        ],
        "registration_number": [
          "3004141078",
          "3024753119",
          "2432235",
          "3003521949",
          "3031697086",
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          "2050012",
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          "3004493545",
          "3008576040",
          "3004438098",
          "2244900",
          "3009984016",
          "3010194621",
          "2182595",
          "9610126",
          "8043379",
          "9610240",
          "2517506",
          "3025430789",
          "3004434309"
        ],
        "fei_number": [
          "3004141078",
          "3024753119",
          "2432235",
          "3003521949",
          "3031697086",
          "3008494306",
          "3010461097",
          "3003795116",
          "3003593973",
          "3003402518",
          "3023197868",
          "3005342322",
          "3048141116",
          "3009473156",
          "3008382976",
          "3050015",
          "3003559191",
          "2050012",
          "3006198300",
          "3002808212",
          "3004493545",
          "3003413192",
          "3008576040",
          "3004438098",
          "2244900",
          "3009984016",
          "3010194621",
          "2182595",
          "2517506",
          "3025430789",
          "3002806559",
          "3004434309"
        ],
        "device_name": "Analyzer, Chemistry, Micro, For Clinical Use",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2170",
        "device_class": "1"
      }
    }
  ]
}