{
  "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,
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  "results": [
    {
      "cfres_id": "35320",
      "product_res_number": "Z-0197-05",
      "event_date_initiated": "2004-09-23",
      "event_date_posted": "2004-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-12-10",
      "res_event_number": "30182",
      "product_code": "NIG",
      "product_description": "Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN",
      "code_info": "Lot #: DX10789, Expiration Date 10/31/2004",
      "firm_fei_number": "1000123732",
      "recalling_firm": "Tosoh Bioscience,  Inc.",
      "address_1": "347 Oyster Point Blvd Ste 201 347 Oyster Point Blvd",
      "address_2": "Ste 201",
      "city": "South San Francisco",
      "state": "CA",
      "postal_code": "94080-1913",
      "additional_info_contact": "Lois Nakayama\n800-248-6764",
      "reason_for_recall": "On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected devices.",
      "root_cause_description": "Other",
      "action": "On 10/30/04, the firm initiated the recall and its notification was via letters requesting return of affected device.",
      "product_quantity": "133 boxes",
      "distribution_pattern": "The firm distributed product to 10 consumers and 1 distributor, to locations in  CA, CO, FL, MD, NY, OH, SC and TX.  No federal government agency sales/distribution centers or foreign countries received the product.  The last product distributed was on 6/15/2004.",
      "openfda": {
        "k_number": [
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          "K020566",
          "K052000",
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          "K023239",
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          "K100375",
          "K033038"
        ],
        "registration_number": [
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          "9612316",
          "1319681",
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          "3005360469",
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          "2122870",
          "3005529799"
        ],
        "device_name": "System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}