{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "55366",
      "product_res_number": "Z-0015-2008",
      "event_date_initiated": "2007-07-24",
      "event_date_posted": "2007-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-18",
      "res_event_number": "39389",
      "product_code": "JIF",
      "k_numbers": [
        "K974620"
      ],
      "product_description": "Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101.  in vitro diagnostic.",
      "code_info": "Lot numbers FL029 exp 8/30/07, GB059 exp 11/30/07, GD005 exp 12/30/07, GE093 exp 1/30/08, GH034 exp 4/30/08, GJ039 exp 7/30/08, HB064 exp 11/30/08, and HD035 exp 1/30/09.",
      "firm_fei_number": "2550000",
      "recalling_firm": "Thermo Fisher Scientific",
      "address_1": "171 Industry Dr",
      "city": "Pittsburgh",
      "state": "PA",
      "postal_code": "15275-1015",
      "additional_info_contact": "Bola Nicholson\n412-747-4039",
      "reason_for_recall": "Method is susceptible to positive interference from endogenous ALT in patient samples.",
      "root_cause_description": "Device Design",
      "action": "The firm has updated the Limitations section of the Ammonia Reagent Package Insert and circulated a Technical Bulletin dated July 24, 2007 to all customers that have purchased Ammonia Reagent that is still within expiration date.  A Notification of Change has been introduced and shall be placed within subsequent Ammonia Reagent Kits with a copy of the updated package insert; the notification of change informs customers that a change has been made to the package insert. Notifications of Change are placed within kits for 6 months from the date of issue.",
      "product_quantity": "6,882 units",
      "distribution_pattern": "Worldwide, including USA, Ecuador, and Canada.",
      "openfda": {
        "k_number": [
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          "K821719",
          "K030873",
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          "1181121",
          "3003795116",
          "3006198300",
          "3013660430",
          "3002806809",
          "3000303338"
        ],
        "device_name": "Enzymatic Method, Ammonia",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1065",
        "device_class": "1"
      }
    }
  ]
}