{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "104078",
      "product_res_number": "Z-0030-2012",
      "event_date_initiated": "2011-06-13",
      "event_date_posted": "2011-10-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-12-11",
      "res_event_number": "59957",
      "product_code": "GHH",
      "k_numbers": [
        "K920668"
      ],
      "product_description": "Minutex D-Dimer ; Trinity Biotech plc,\nBray,\nCo. Wicklow,\nIreland.\nTel: (353) 1 276 9800,\nFax: (353) 1 276 9888,\nWeb: www.trinitybiotech.com\n\nMinutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.",
      "code_info": "510 K number: K920668  Device listing number: D099358 Lot Numbers:\tExpiry Date: C040002\t10 July 2012 C042002\t14 Jan 2012 B218005\t05 Jan 2012 B341002\t03 May 2012 B144001\t30 Sept 2011",
      "firm_fei_number": "3005261996",
      "recalling_firm": "Tcoag Us, Incorporated",
      "address_1": "330 Waterloo Valley Rd",
      "city": "Budd Lake",
      "state": "NJ",
      "postal_code": "07828-1395",
      "additional_info_contact": "Mr. Thomas Lawlor\n973-631-1200",
      "reason_for_recall": "There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Dimer.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm,Tcoag US, Incorporated, sent an \"Urgent Device Recall\" letter dated June 13, 2011 via UPS to its customers. The letter describes the product, problem and actions to be taken.  The customers were instructed to immediately examine their inventory and quarantine the products subject to recall; complete and return the attached Product Recall Notification Response Form by June 22, 2011 via fax at 973-775-3085; scrap the products consistent with their laboratory policy and if they have further distributed these products, notify their customers to quarantine and scrap the recalled product.\n\nFor questions or technical assistance,  please call the Tcoag hotline at 1-888-291-0415, option 2 (7.30 am to 6.00 pm Eastern Time).",
      "product_quantity": "4409 Units",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and country of: Canada.",
      "openfda": {
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          "K812298",
          "K070453",
          "K030740",
          "K993276",
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          "K852176",
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          "K880077",
          "K852848",
          "K852520",
          "K112120",
          "K893961",
          "K890399"
        ],
        "registration_number": [
          "2032900",
          "9612316",
          "3013660430",
          "9680746",
          "2084025",
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        "fei_number": [
          "3004185580",
          "3002808328",
          "3013660430",
          "2084025",
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          "3003565434",
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          "1181121",
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        ],
        "device_name": "Fibrin Split Products",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2"
      }
    }
  ]
}