{
  "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": "114204",
      "product_res_number": "Z-0807-2013",
      "event_date_initiated": "2012-08-20",
      "event_date_posted": "2013-02-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-06-04",
      "res_event_number": "63558",
      "product_code": "LLH",
      "product_description": "Remel Xpect Clostridium difficile Toxin A/B, IVD,  40 clostridium difficile toxin A/B tests, REF 24640.\n\nProduct Usage:\nThe test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.",
      "code_info": "Lot 141764",
      "firm_fei_number": "1924669",
      "recalling_firm": "Remel Inc",
      "address_1": "12076 Santa Fe Trail Dr",
      "city": "Lenexa",
      "state": "KS",
      "postal_code": "66215-3519",
      "additional_info_contact": "913-888-0939",
      "reason_for_recall": "The firm is recalling the products due to a potential for false negative test results.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Thermo Fisher sent  a recall notification letter with details of the recall on August 20, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken.  Customers were requested to follow the instructions provided and fax back the attached \"Acknowledgement  & Receipt Form\" to 1-877-428-1924 (toll free in the US) or 1-913-895-4190  (International).  For questions contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).",
      "product_quantity": "50 units",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom",
      "openfda": {
        "k_number": [
          "K964887",
          "K003306",
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        "device_name": "Reagents, Clostridium Difficile Toxin",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2660",
        "device_class": "1"
      }
    }
  ]
}