{
  "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": [
    {
      "status": "Terminated",
      "city": "Malmo",
      "state": "",
      "country": "Sweden",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80684",
      "recalling_firm": "Euro Diagnostica AB",
      "address_1": "Box 50117",
      "address_2": "Lundavagen 151",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "MN",
      "recall_number": "Z-2919-2018",
      "product_description": "is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.",
      "product_quantity": "4",
      "reason_for_recall": "Incorrectly labeled  Manufactured by DiaSorin,  The correct term should be Distributed by DiaSorin.",
      "recall_initiation_date": "20161021",
      "center_classification_date": "20180823",
      "termination_date": "20191105",
      "report_date": "20180829",
      "code_info": "Lot #'s: TS2725 (kit) and TS 2733 (PC)",
      "more_code_info": ""
    }
  ]
}