{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "36807",
      "product_res_number": "Z-0632-05",
      "event_date_initiated": "2004-01-23",
      "event_date_posted": "2005-03-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-07-22",
      "res_event_number": "30919",
      "product_code": "MID",
      "k_numbers": [
        "K001981"
      ],
      "product_description": "DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA.  Catalog No.: 7800.  Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN  55082-0285",
      "code_info": "catalog # 7800, lot # 039229, expiration date 12/23/04",
      "firm_fei_number": "2182595",
      "recalling_firm": "Diasorin Inc.",
      "address_1": "1951 Northwestern Ave S",
      "city": "Stillwater",
      "state": "MN",
      "postal_code": "55082-7536",
      "additional_info_contact": "DiaSorin Technical Services\n800-328-1482",
      "reason_for_recall": "DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.",
      "root_cause_description": "Other",
      "action": "Customers were notified via a letter which described the product and the problem. Recommended to destroy all affected kits and stated that the kits will be replaced.",
      "product_quantity": "16 kits",
      "distribution_pattern": "GA, NY & KS",
      "openfda": {
        "k_number": [
          "K012053",
          "K000920",
          "K946215",
          "K955449",
          "K921250",
          "K970177",
          "K983695",
          "K020156",
          "K952523",
          "K920401",
          "K223093",
          "K020752",
          "K946385",
          "K060176",
          "K946216",
          "K924421",
          "K001981",
          "K023433",
          "K935288",
          "K984173",
          "K984347",
          "K024195",
          "K020758",
          "K911680",
          "K946217",
          "K001574",
          "K946034",
          "K021192",
          "K952522",
          "K932225",
          "K951187",
          "K003069",
          "K020241",
          "K102425",
          "K984175",
          "K951363",
          "K921265",
          "K030741",
          "K941840",
          "K913054",
          "K012450",
          "K992440",
          "K971784",
          "K092181",
          "K933393",
          "K013018",
          "K933588",
          "K022990",
          "K983694",
          "K932373",
          "K923886",
          "K984102",
          "K962926",
          "K953291",
          "K022992",
          "K952520",
          "K933784",
          "K993085",
          "K923320",
          "K131821",
          "K040463",
          "K973196",
          "K113020",
          "K911661",
          "K012449",
          "K933788",
          "K920400",
          "K955303",
          "K983696",
          "K933392",
          "K952287",
          "K952521",
          "K130528",
          "K981021",
          "K020757",
          "K922351",
          "K914405",
          "K971039",
          "K032868",
          "K981014",
          "K962469",
          "K981020",
          "K032240",
          "K940403",
          "K120817",
          "K983692",
          "K103834",
          "K933786",
          "K091845",
          "K012567",
          "K024196",
          "K021398",
          "K953366",
          "K992449"
        ],
        "device_name": "System, Test, Anticardiolipin Immunological",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5660",
        "device_class": "2",
        "registration_number": [
          "1721937",
          "9610566",
          "2026994",
          "2245285",
          "3022178699",
          "2915274",
          "3004973408",
          "1529254",
          "2242436",
          "3037000637",
          "2029372",
          "9680745",
          "1181055",
          "1222302",
          "1217183",
          "1832216",
          "3003825930",
          "8043792",
          "9610746",
          "2918768",
          "3012348571",
          "3002800697",
          "3039353646",
          "3032705",
          "1421346"
        ],
        "fei_number": [
          "3002808269",
          "2026994",
          "2245285",
          "1000305932",
          "3022178699",
          "1000306617",
          "2915274",
          "3004973408",
          "2242436",
          "3037000637",
          "3005774014",
          "3002701146",
          "1000121039",
          "1000117401",
          "1181055",
          "1217183",
          "1832216",
          "3003825930",
          "2918768",
          "3012348571",
          "3002800697",
          "3002806557",
          "3039353646",
          "3002807876",
          "1421346"
        ]
      }
    }
  ]
}