{
  "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
    }
  },
  "results": [
    {
      "cfres_id": "140563",
      "product_res_number": "Z-0164-2016",
      "event_date_initiated": "2015-09-22",
      "event_date_posted": "2015-10-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-03-30",
      "res_event_number": "72311",
      "product_code": "JIF",
      "k_numbers": [
        "K051114"
      ],
      "product_description": "Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.",
      "code_info": "Lot 50083Y600, expiration date 31 Jul 2016.",
      "firm_fei_number": "3000303338",
      "recalling_firm": "Sentinel CH SpA",
      "address_1": "Via Robert Koch 2 2 via robert koch",
      "city": "Milano",
      "country": "Italy",
      "reason_for_recall": "Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.",
      "root_cause_description": "Process control",
      "action": "Sentinel Urgent Field Safety Notice issued on 9/22/15  by Abbott to customers, including their US customers.\nActions to be Taken\n1. Immediately discontinue use of lot 50083Y600 and destroy any remaining inventory.\n2. Order a replacement Ammonia Ultra reagent lot.\n3. Follow your individual laboratory protocol regarding reviewing previously reported patient results.\n4. Please retain this communication for future reference. If you have forwarded any MULTIGENT Ammonia Ultra reagent lot 50083Y600 to another laboratory, please provide a copy of this letter to them.\nContacts\nIf you or any of the health care providers you serve have any questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT.",
      "product_quantity": "765 kits",
      "distribution_pattern": "Nationwide Distribution.",
      "openfda": {
        "k_number": [
          "K870787",
          "K030873",
          "K913124",
          "K123677",
          "K840770",
          "K033921",
          "K984402",
          "K760332",
          "K821719",
          "K001285",
          "K870143",
          "K123320",
          "K974620",
          "K062316",
          "K770273",
          "K872110",
          "K051114",
          "K964565",
          "K934925",
          "K981467",
          "K915707",
          "K003196",
          "K023841",
          "K981920",
          "K183517",
          "K932556",
          "K770363",
          "K021151",
          "K864706",
          "K880651"
        ],
        "registration_number": [
          "3004493545",
          "9610126",
          "3005333358",
          "3002809144",
          "2050010",
          "3003795116",
          "3013660430",
          "1181121",
          "2432235",
          "2085064",
          "1827821",
          "2517506",
          "2050012",
          "9681753",
          "9610529",
          "3006198300",
          "3010825766",
          "8020316"
        ],
        "fei_number": [
          "1000135102",
          "3004493545",
          "2050010",
          "3005333358",
          "3002809144",
          "3002806809",
          "3003795116",
          "3013660430",
          "1181121",
          "2432235",
          "1827821",
          "2517506",
          "3006198300",
          "3010825766",
          "2050012",
          "3000303338",
          "3002806559",
          "3002806560"
        ],
        "device_name": "Enzymatic Method, Ammonia",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1065",
        "device_class": "1"
      }
    }
  ]
}