{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "55507",
      "product_res_number": "Z-0039-2008",
      "event_date_initiated": "2007-07-30",
      "event_date_posted": "2007-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-17",
      "res_event_number": "39419",
      "product_code": "GKP",
      "k_numbers": [
        "K961579"
      ],
      "product_description": "STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.",
      "code_info": "BT7 7016065; BT7 7016067; BT7 7016068; BT7 7016072; BT7 7016074; BT7 7016075; BT8 7016076; BT7 7016078; BT7 7017080; BT7 7016090; BT7 7016091; BT8 7026119; BT8 7026126; BT8 7026127; BT8 7026128; BT8 7026130; BT7 7026134; BT7 7026135; BT7 7026140; BT8 7026146; BT8 7026147; BT8 7026148; BT8 7026149; BT8 7026150; BT7 7026151; BT7 7026152; BT7 7026153; BT7 7026154; BT7 7026155; BT7 7026156; BT7 7026157; BT7 7036164; BT7 7036166; BT7 7036167; BT7 7036168; BT7 7036177; BT7 7036192.",
      "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": "973-631-1200",
      "reason_for_recall": "Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.",
      "root_cause_description": "Process design",
      "action": "Recall notification letters were mailed to consignees on 7/30/07 by first class mail.",
      "product_quantity": "41 units installed",
      "distribution_pattern": "Nationwide.",
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        "device_name": "Instrument, Coagulation, Automated",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5400",
        "device_class": "2"
      }
    }
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}