{
  "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,
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  "results": [
    {
      "cfres_id": "41029",
      "product_res_number": "Z-0172-06",
      "event_date_initiated": "2005-07-29",
      "event_date_posted": "2005-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-03-01",
      "res_event_number": "32887",
      "product_code": "DAP",
      "k_numbers": [
        "K041438"
      ],
      "product_description": "Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.",
      "code_info": "Catalog number OQWM",
      "firm_fei_number": "2517506",
      "recalling_firm": "Dade Behring , Inc.",
      "address_1": "500 GBC Dr., Mailstop 514 500 GBC Dr. Mailstop 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19714-6101",
      "additional_info_contact": "Aydee Crawford\n302-631-6312",
      "reason_for_recall": "Reports of false negative results on Sysmex Coagulation System.",
      "root_cause_description": "Other",
      "action": "On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.",
      "product_quantity": "2987 units",
      "distribution_pattern": "The product was shipped to medical facilities nationwide.",
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        "device_name": "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2"
      }
    }
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}