{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "36243",
      "product_res_number": "Z-0538-05",
      "event_date_initiated": "2004-12-03",
      "event_date_posted": "2005-02-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-10-18",
      "res_event_number": "30634",
      "product_code": "DAP",
      "k_numbers": [
        "K041438"
      ],
      "product_description": "Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.",
      "code_info": "Lot numbers 544531 to 544548 and 544502 to 544504.",
      "firm_fei_number": "2517506",
      "recalling_firm": "Dade Behring , Inc.",
      "address_1": "Rte 896, Glasgow Business Community Rte 896 Glasgow Business Community",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702",
      "additional_info_contact": "Donna Wolf\n302-631-0384",
      "reason_for_recall": "decrease in product stability after reconstitution and reduced stability on board certain instrument systems",
      "root_cause_description": "Other",
      "action": "The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.",
      "product_quantity": "25381 units",
      "distribution_pattern": "The product was shipped nationwide to medical facilities.",
      "openfda": {
        "k_number": [
          "K003267",
          "K141144",
          "K890189",
          "K915203",
          "K002948",
          "K972696",
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          "K040437",
          "K070927",
          "K943787",
          "K080069",
          "K973819",
          "K002706",
          "K030328",
          "K920943",
          "K862156",
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          "K915698",
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          "K882944",
          "K032419",
          "K172903",
          "K110303",
          "K160885",
          "K012755",
          "K162227",
          "K013545",
          "K020810",
          "K915503",
          "K090264",
          "K081732",
          "K050544",
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          "K022976",
          "K013544",
          "K033491",
          "K943571",
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          "K041438",
          "K932657",
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          "K093626",
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        "registration_number": [
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          "3005360469",
          "8020790",
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        "fei_number": [
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          "1000611339",
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          "1217183",
          "2517506",
          "3005670738",
          "3013660430",
          "1000306617"
        ],
        "device_name": "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2"
      }
    }
  ]
}