{
  "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-2921-2018",
      "product_description": "is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.",
      "product_quantity": "6",
      "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: TS 2819 (kit) and TS 2841 (PC)",
      "more_code_info": ""
    }
  ]
}