{
  "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": {
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      "limit": 1,
      "total": 16
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  "results": [
    {
      "cfres_id": "41476",
      "product_res_number": "Z-0131-06",
      "event_date_initiated": "2005-08-18",
      "event_date_posted": "2005-11-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-08-25",
      "res_event_number": "33199",
      "product_code": "JPK",
      "k_numbers": [
        "K952720"
      ],
      "product_description": "Tosoh brand Glycohemoglobin A1c Controls I & II,\nCatalog Number: 992133;\n\n\nProduct is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.",
      "code_info": "Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA",
      "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",
      "reason_for_recall": "The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.",
      "root_cause_description": "Other",
      "action": "On August 18, 2005, the firm initiated the recall and issued notification to its consignees via mail, including instructions for distributors of the recall.",
      "product_quantity": "3,284 boxes",
      "distribution_pattern": "The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.",
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        "device_name": "Mixture, Hematology Quality Control",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.8625",
        "device_class": "2"
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}