{
  "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 II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79183",
      "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": "Worldwide Distribution and US. Nationwide",
      "recall_number": "Z-0929-2018",
      "product_description": "DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200.    Product Usage:  The DIASTAT¿ 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.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.",
      "product_quantity": "1090",
      "reason_for_recall": "Complaint investigation concluded that although product quality  requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the  strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample  test results for the two FANA200 kit lots SS 1500 and SS 2009.",
      "recall_initiation_date": "20151015",
      "center_classification_date": "20180308",
      "termination_date": "20190329",
      "report_date": "20180314",
      "code_info": "UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009."
    }
  ]
}