{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "45344",
      "product_res_number": "Z-0875-06",
      "event_date_initiated": "2006-04-03",
      "event_date_posted": "2006-05-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-08-07",
      "res_event_number": "35112",
      "product_code": "JHX",
      "k_numbers": [
        "K984067"
      ],
      "product_description": "Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic.",
      "code_info": "Lot #245276002; 245289002; 245304002; 245318002; 245332002; 245361002; 246023002; 246037002; 246051002; 246065002; and 246079002",
      "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": "Fran Dillon\n302-631-6951",
      "reason_for_recall": "Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids.  Erroneous test results may be generated without an associated error code.  Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.",
      "root_cause_description": "Other",
      "action": "Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old.  In addition, each customer is being contacted by phone as an effectiveness verification.  Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.",
      "product_quantity": "3229 cartons of 100 TestPaks",
      "distribution_pattern": "Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark,  and Australia.",
      "openfda": {
        "k_number": [
          "K972782",
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          "K033747",
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          "K881237",
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          "K890543",
          "K913298",
          "K813573",
          "K791582",
          "K801318",
          "K801728",
          "K030012"
        ],
        "registration_number": [
          "2432235",
          "9612316",
          "8031673",
          "3005360469",
          "3005529799",
          "3029973107",
          "3002642396",
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          "1036362",
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          "9680746",
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          "2517506",
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          "3000308930",
          "1319681",
          "2435505",
          "3005333358",
          "3007135420",
          "3012963943",
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        "fei_number": [
          "3002808328",
          "2432235",
          "3005670738",
          "1000206808",
          "3005529799",
          "3029973107",
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          "3002807710",
          "1036362",
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          "3008344661",
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          "3000308930",
          "3007135420",
          "2967",
          "3005333358",
          "3012963943",
          "3013982035"
        ],
        "device_name": "Fluorometric Method, Cpk Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}