{
  "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": "216040",
      "product_res_number": "Z-0205-2026",
      "event_date_initiated": "2025-09-12",
      "event_date_posted": "2025-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "97596",
      "product_code": "DAP",
      "k_numbers": [
        "K141144",
        "K162227",
        "K964728"
      ],
      "product_description": "Product: STA Liatest D-Di;\nREF: 00515;",
      "code_info": "REF: 00515;\nUDI-DI: 03607450005158;\nLot numbers: 271382, 271411;\nExpiration 09/30/2025;",
      "firm_fei_number": "2245451",
      "recalling_firm": "Diagnostica Stago, Inc.",
      "address_1": "5 Century Dr",
      "city": "Parsippany",
      "state": "NJ",
      "postal_code": "07054-4607",
      "additional_info_contact": "Technical Hotline\n800-7250607",
      "reason_for_recall": "A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On September 12, 2025 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were emailed to customers. Actions for customers: Discontinue use of affected lots and dispose of them in accordance with your local regulations. Complete and return response form. For additional information, please contact Stago's 24/7 Hotline at 1-800-725-0607.",
      "product_quantity": "12740 units",
      "distribution_pattern": "Worldwide distribution- US Nationwide and the country of Canada.",
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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"
      }
    }
  ]
}