{
  "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,
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  },
  "results": [
    {
      "cfres_id": "35321",
      "product_res_number": "Z-0218-05",
      "event_date_initiated": "2003-04-02",
      "event_date_posted": "2004-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-06-15",
      "res_event_number": "30183",
      "product_code": "NIG",
      "k_numbers": [
        "K971103"
      ],
      "product_description": "TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media",
      "code_info": "All units of these models.",
      "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\n650-615-4970",
      "reason_for_recall": "A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.",
      "root_cause_description": "Other",
      "action": "The firm initiated the correction on 4/2/03 via telephone calls and PR on 11/24/04 to all its direct customers, however, the firm indicated that software upgrade was accomplished by the firm's Field Service Engineers.",
      "product_quantity": "81 units",
      "distribution_pattern": "81 customers received the upgrade, including customers who received instruments with the upgrade installed already.  37 customers received the v.3.12 installation.  In addition, TOSOH bioscience has identified 3 foreign and 5 US customers who required the upgrade. The firm had distributed to 3 US Government medical centers as well. These upgrades have been completed.",
      "openfda": {
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        ],
        "registration_number": [
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        ],
        "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"
      }
    }
  ]
}