{
  "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": "154980",
      "product_res_number": "Z-0306-2018",
      "event_date_initiated": "2017-02-14",
      "event_date_posted": "2017-12-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-05-16",
      "res_event_number": "77107",
      "product_code": "LKJ",
      "k_numbers": [
        "K932876"
      ],
      "product_description": "Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA\n\nDIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.",
      "code_info": "Lot:  TS 2076",
      "firm_fei_number": "3007610287",
      "recalling_firm": "Euro Diagnostica AB",
      "address_1": "Box 50117 151 lundavagen",
      "address_2": "Box 50117",
      "city": "Malmo",
      "country": "Sweden",
      "additional_info_contact": "Malin Bornschein\n4640537600",
      "reason_for_recall": "Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076.  The kit might not perform correctly and so potentially yield false positive samples.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Consignees were notified by phone or email beginning 2/15/2017.  The Urgent Field Safety Notice identified affected product, described the issue, and stated affected product should be destroyed.  A response form was asked to be returned.   Questions can be directed to Malin Bornschein at malin.bornschein@eurodiagnostica.com",
      "product_quantity": "534 kits",
      "distribution_pattern": "MN, NE, TX",
      "openfda": {
        "k_number": [
          "K873249",
          "K034013",
          "K954392",
          "K862313",
          "K913342",
          "K954891",
          "K030775",
          "K984473",
          "K842563",
          "K874115",
          "K021103",
          "K932679",
          "K082759",
          "K932876",
          "K883949",
          "K024223",
          "K993294",
          "K882740",
          "K024226",
          "K984464",
          "K864668",
          "K914454",
          "K894411",
          "K984478",
          "K831463",
          "K210902",
          "K961815",
          "K842484",
          "K883883",
          "K932302",
          "K113610",
          "K954723",
          "K011244",
          "K885224",
          "K920150",
          "K024218",
          "K921132",
          "K912291",
          "K893897",
          "K954700",
          "K041658",
          "K024232",
          "K042416",
          "K984470",
          "K893896",
          "K021257",
          "K984475",
          "K931255",
          "K081104",
          "K914550"
        ],
        "registration_number": [
          "2915274",
          "3004973408",
          "8043792",
          "9610566",
          "3003825930",
          "2242436",
          "2026994",
          "2918768",
          "3003935253",
          "3007208259",
          "3015376545",
          "1318354",
          "1181055",
          "3039353646",
          "3032705",
          "9680745"
        ],
        "fei_number": [
          "2915274",
          "3004973408",
          "3002808269",
          "3003825930",
          "2242436",
          "2026994",
          "2918768",
          "3007208259",
          "3005774014",
          "3015376545",
          "3002701146",
          "1318354",
          "1181055",
          "3039353646",
          "3002807876",
          "3003935253"
        ],
        "device_name": "Antinuclear Antibody, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2"
      }
    }
  ]
}