{
  "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": "Uppsala",
      "state": "N/A",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79438",
      "recalling_firm": "Phadia Ab",
      "address_1": "Rapsgatan Plant",
      "address_2": "Rapsgatan 7",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR",
      "recall_number": "Z-1276-2018",
      "product_description": "Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.",
      "product_quantity": "2307",
      "reason_for_recall": "We want to inform all Phadia 250 system operators performing EliA Assays not to use the function  OK to All  in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the  OK  function may be used for rejecting single tests and dilution of samples in accordance with product DfU).",
      "recall_initiation_date": "20171120",
      "center_classification_date": "20180330",
      "termination_date": "20190306",
      "report_date": "20180411",
      "code_info": "Phadia Prime software 12-4101-00  Phadia 250 12-3900-01    Listed software:  EliA dsDNA Well 14-5500-01  EliA U1RNP Well 14-5501-01  EliA Sm Well 14-5502-01  EliA Ro Well 14-5503-01  EliA La Well 14-5504-01  EliA CENP Well 14-5505-01  EliA Scl-70 Well 14-5506-01  EliA Jo-1 Well 14-5507-01  EliA Symphony Well 14-5508-01  EliA RNP70 Well 14-5511-01  EliA GBM Well 14-5514-01  EliA CCP Well 14-5515-01  EliA Celikey IgA Well 14-5517-01  EliA Celikey IgG Well 14-5518-01  EliA Gliadin IgA Well 14-5519-01  EliA Gliadin IgG Well 14-5520-01  EliA Cardiolipin IgA Well 14-5528-01  EliA Cardiolipin IgG Well 14-5529-01  EliA Cardiolipin IgM Well 14-5530-01  EliA B2-Glycoprotein I IgA Well 14-5531-01  EliA B2-Glycoprotein I IgG Well 14-5532-01  EliA B2-Glycoprotein I IgM Well 14-5533-01  EliA PR3S Well 14-5536-01  EliA MPOS Well 14-5537-01  EliA GliadinDP IgA Well 14-5538-01  EliA GliadinDP IgG Well 14-5539-01  EliA RF IgM Well 14-5600-01  EliA RF IgA Well 14-5601-01  EliA SmDP Well 14-5624-01  EliA Scl-70S Well 14-5637-01  EliA anti-TPO Well 14-5641-01  EliA anti-TG Well 14-5642-01  EliA M2 Well 14-5649-01"
    }
  ]
}