{
  "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": "N/A",
      "country": "Sweden",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77426",
      "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": "E-Mail",
      "distribution_pattern": "MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada",
      "recall_number": "Z-2627-2017",
      "product_description": "DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.",
      "product_quantity": "501 units",
      "reason_for_recall": "FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.",
      "recall_initiation_date": "20170522",
      "center_classification_date": "20170623",
      "termination_date": "20210331",
      "report_date": "20170705",
      "code_info": "TS 3577"
    }
  ]
}