{
  "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": "150602",
      "product_res_number": "Z-0646-2017",
      "event_date_initiated": "2016-08-16",
      "event_date_posted": "2016-11-21",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-02-27",
      "res_event_number": "75511",
      "product_code": "GHH",
      "k_numbers": [
        "K072288"
      ],
      "product_description": "Pathfast D-Dimer, Reference number: PF1051-KUS",
      "code_info": "Lot T528",
      "firm_fei_number": "3010736318",
      "recalling_firm": "Lsi Medience Corporation",
      "address_1": "13-4 Uchikanda 1 Chome 13-4 Uchikanda",
      "city": "Tokyo",
      "state": "1 Chome",
      "country": "Japan",
      "additional_info_contact": "Roger Hanfin\n704-547-6517",
      "reason_for_recall": "Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Customers were notified by letter sent via email on/about August 1, 2016.\n\nThey were instructed to stop using and destroy the affected kits. They were to perform a retrospective analysis of the patients tested on the batch and investigate further. A Destruction Certificate was attached to be completed and returned to Verbatim Americas, LLC.\n\nFor further questions please call (704) 547-6517.",
      "product_quantity": "42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).",
      "distribution_pattern": "US Distribution to the states of : AL, FL, ID and MA.",
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        "device_name": "Fibrin Split Products",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2",
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