{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "181300",
      "product_res_number": "Z-2117-2020",
      "event_date_initiated": "2020-04-24",
      "event_date_posted": "2020-05-12",
      "recall_status": "Open, Classified",
      "res_event_number": "85590",
      "product_code": "LCD",
      "k_numbers": [
        "K102699"
      ],
      "product_description": "ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.",
      "code_info": "MODEL: 1P31-25 LOT NUMBERS: 04281BE00, 08510BE00 and 11221BE00 Shelf life per LOT: 04281BE00;2020-MAY-21 08510BE00; 2020-AUG-08 11221BE00;2020-NOV-18",
      "firm_fei_number": "3002809144",
      "recalling_firm": "Abbott Gmbh & Co. KG",
      "address_1": "Max-Planck-Ring 2 2 max-planck-ring",
      "city": "Wiesbaden",
      "postal_code": "65205",
      "country": "Germany",
      "additional_info_contact": "Dana Schmidt\n224-667-8598",
      "reason_for_recall": "Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and\nSTAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when\nprocessed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 24, 2020, Abbott issued a Product Correction letter to all customers who received shipments of the three impacted lots of ARCHITECT iGenatamicin Reagent kits. U.S. customers were sent the letter via FedEx priority overnight express. In the U.S., the customers will be requested to return to Abbott a Customer Reply Form acknowledging the receipt or a request for assistance.",
      "product_quantity": "6087 Reagent Kits",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, ND, NE, NJ, NV, NY, OH, OK, PA, RI, SC, TN,TX, UT, VA, VT,  WA, WI, PR.\n\nThe countries of Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Curacao, Czech Republic, Faroe Islands, France, Germany, Greece, Greenland, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Namibia, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Philippines, Poland, Portugal, Republic of Yemen, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tunisia, UAE, United Kingdom and Uruguay.",
      "openfda": {
        "k_number": [
          "K800150",
          "K012978",
          "K831416",
          "K895484",
          "K935376",
          "K042479",
          "K010984",
          "K904305",
          "K832056",
          "K831304",
          "K862260",
          "K012311",
          "K850060",
          "K873855",
          "K811744",
          "K832445",
          "K874703",
          "K860045",
          "K020704",
          "K900703",
          "K823387",
          "K060709",
          "K811692",
          "K943982",
          "K913470",
          "K893912",
          "K940376",
          "K873854",
          "K953020",
          "K962819",
          "K243500",
          "K102699",
          "K852672",
          "K903743",
          "K962519",
          "K871329",
          "K860868"
        ],
        "registration_number": [
          "1219913",
          "1319681",
          "3002809144",
          "2050010",
          "3010939897",
          "2432235",
          "3004493545",
          "1319808",
          "3033967997",
          "3002642396",
          "3000308930",
          "3003561301",
          "3010825766",
          "3005755244",
          "3012963943",
          "8020888",
          "3002806944",
          "2050012",
          "2250051",
          "3006198300",
          "3005333358",
          "2517506"
        ],
        "fei_number": [
          "3007019572",
          "1219913",
          "2050010",
          "3002809144",
          "3010939897",
          "2432235",
          "3004493545",
          "3033967997",
          "3002642396",
          "3000308930",
          "3003561301",
          "3010825766",
          "3005755244",
          "3012963943",
          "3002806944",
          "2050012",
          "2250051",
          "3006198300",
          "3005333358",
          "2517506",
          "1000136573",
          "1000305841"
        ],
        "device_name": "Enzyme Immunoassay, Gentamicin",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3450",
        "device_class": "2"
      }
    }
  ]
}