{
  "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": "74061",
      "product_res_number": "Z-0668-2009",
      "event_date_initiated": "2008-06-23",
      "event_date_posted": "2009-01-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-01-29",
      "res_event_number": "49711",
      "product_code": "JHX",
      "k_numbers": [
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      ],
      "product_description": "Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.",
      "code_info": "Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.",
      "firm_fei_number": "2517506",
      "recalling_firm": "Dade Behring, Inc.",
      "address_1": "500 GBC Drive, Mailstop 514 500 GBC Drive Mailstop 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19714-6101",
      "additional_info_contact": "Siemens Customer Service Center\n800-241-0420",
      "reason_for_recall": "Incorrect result: Potential for false elevation of CTnI results",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.",
      "product_quantity": "5868 cartons",
      "distribution_pattern": "Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.",
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        "device_name": "Fluorometric Method, Cpk Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
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}