{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 12
    }
  },
  "results": [
    {
      "cfres_id": "34853",
      "product_res_number": "Z-0214-05",
      "event_date_initiated": "2004-08-30",
      "event_date_posted": "2004-11-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-10-03",
      "res_event_number": "29963",
      "product_code": "MID",
      "k_numbers": [
        "K981021"
      ],
      "product_description": "Cardiolipin IgM ELISA Test System, Product Number 438450CE.  The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.).  The individual vials are secured in the card board box.  The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.",
      "code_info": "Lot 04027128 exp 2005-10",
      "firm_fei_number": "2242436",
      "recalling_firm": "Zeus Scientific Inc",
      "address_1": "200 Evans Way",
      "city": "Somerville",
      "state": "NJ",
      "postal_code": "08876-3767",
      "additional_info_contact": "Mark Kopnitsky\n800-286-2111 Ext. 237",
      "reason_for_recall": "During packaging, Lyme plates were packaged in this kit in error.",
      "root_cause_description": "Other",
      "action": "Wampole Laboratories was contacted by Zeus on 8/30/3004.  Wampole customers were then contacted by phone and letter to destroy all products on hand.",
      "product_quantity": "25 kits",
      "distribution_pattern": "25 units were sent directly from Zeus to their direct account Wampole Laboratories.   The distributor contacted their customers to discard all affected kits.  8 units were shipped overseas to Israel.  There were no ships to government facilities.",
      "openfda": {
        "k_number": [
          "K946385",
          "K024196",
          "K955449",
          "K973196",
          "K951363",
          "K971784",
          "K923320",
          "K022992",
          "K021192",
          "K003069",
          "K914405",
          "K984102",
          "K983696",
          "K021398",
          "K012449",
          "K984175",
          "K962469",
          "K000920",
          "K993085",
          "K946034",
          "K983694",
          "K932225",
          "K020156",
          "K001574",
          "K911680",
          "K953291",
          "K092181",
          "K913054",
          "K020752",
          "K983695",
          "K924421",
          "K911661",
          "K920400",
          "K933588",
          "K981020",
          "K103834",
          "K040463",
          "K060176",
          "K001981",
          "K971039",
          "K935288",
          "K032868",
          "K952523",
          "K921265",
          "K933786",
          "K023433",
          "K946217",
          "K981021",
          "K962926",
          "K952287",
          "K984347",
          "K032240",
          "K130528",
          "K030741",
          "K113020",
          "K022990",
          "K946216",
          "K955303",
          "K024195",
          "K921250",
          "K932373",
          "K952520",
          "K020241",
          "K952522",
          "K933784",
          "K951187",
          "K984173",
          "K946215",
          "K020758",
          "K933392",
          "K013018",
          "K012567",
          "K940403",
          "K120817",
          "K933393",
          "K953366",
          "K922351",
          "K952521",
          "K992440",
          "K981014",
          "K020757",
          "K091845",
          "K223093",
          "K131821",
          "K920401",
          "K983692",
          "K992449",
          "K970177",
          "K923886",
          "K941840",
          "K012450",
          "K933788",
          "K012053",
          "K102425"
        ],
        "registration_number": [
          "2245285",
          "9610566",
          "3003825930",
          "9680745",
          "2915274",
          "2029372",
          "1421346",
          "2026994",
          "1529254",
          "1217183",
          "1222302",
          "9610746",
          "3037000637",
          "2918768",
          "3039353646",
          "1721937",
          "1181055",
          "8043792",
          "2242436",
          "3004973408",
          "3012348571",
          "3022178699",
          "3002800697",
          "3032705",
          "1832216"
        ],
        "fei_number": [
          "2245285",
          "3003825930",
          "1000305932",
          "2915274",
          "1421346",
          "2026994",
          "1217183",
          "3002800697",
          "3037000637",
          "1000121039",
          "3002806557",
          "1000306617",
          "2918768",
          "3039353646",
          "3005774014",
          "1181055",
          "2242436",
          "3002807876",
          "3004973408",
          "3012348571",
          "3002808269",
          "3022178699",
          "3002701146",
          "1000117401",
          "1832216"
        ],
        "device_name": "System, Test, Anticardiolipin Immunological",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5660",
        "device_class": "2"
      }
    }
  ]
}