{
  "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": "126739",
      "product_res_number": "Z-0131-2015",
      "event_date_initiated": "2014-04-07",
      "event_date_posted": "2014-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-04-01",
      "res_event_number": "67987",
      "product_code": "CHI",
      "product_description": "Lipase Reagent, 7D80.\n\nUsed to measure lipase in human serum on the Architect system.",
      "code_info": "lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11.",
      "firm_fei_number": "1628664",
      "recalling_firm": "Abbott Laboratories, Inc",
      "address_1": "1921 Hurd Dr",
      "city": "Irving",
      "state": "TX",
      "postal_code": "75038-4313",
      "additional_info_contact": "877-422-2688",
      "reason_for_recall": "Package inserts have incorrect SmartWash parameters for Triglyceride.",
      "root_cause_description": "Labeling Change Control",
      "action": "Firm issued a Product Correction Letter to all Lipase reagent customers who received lots 43827UQ12, 43819UQ03, 44449UQ05, 44127UQ06, 44334UQ07, 43994UQ07, 44596UQ08, 44775UQ09, and 44930UQ11.  The letter identified the affected product and provided an explanation of the problem, as well as, the patient impact and actions to be taken.  The Product Correction Letter provided guidance for the laboratory to correctly configure the Architect cSystem's Lipase assay parameters.  Customers are to retain a copy of the letter for their lab records, and forward a copy to any laboratories that the product was further distributed to.  Questions should be directed to Customer Service at 1-877-4ABBOTT or your local customer service for customers outside of the US.",
      "product_quantity": "11916 units",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.",
      "openfda": {
        "k_number": [
          "K900827",
          "K845027",
          "K760786",
          "K921249",
          "K920337",
          "K941085",
          "K811553",
          "K884596",
          "K923917",
          "K952816",
          "K961179",
          "K802842",
          "K952647",
          "K875173",
          "K874640",
          "K970905",
          "K952180",
          "K897150",
          "K874027",
          "K862312"
        ],
        "registration_number": [
          "2050012",
          "1220972",
          "3004493545",
          "2032900",
          "1319681",
          "3013660430",
          "3014325803",
          "2050010",
          "3002809144",
          "3005094123",
          "3016438761",
          "9610126",
          "2250051",
          "3021841051",
          "3003741796",
          "3012240236",
          "1827821",
          "3000148879",
          "2517506",
          "9681753",
          "8020316",
          "1319809",
          "3005333358",
          "3010825766",
          "2432235",
          "3007662974",
          "3003539867",
          "2247288",
          "8040374"
        ],
        "fei_number": [
          "2050012",
          "1220972",
          "3004493545",
          "3013660430",
          "3000303338",
          "3014325803",
          "5864",
          "1000305840",
          "2050010",
          "3002809144",
          "3005094123",
          "3016438761",
          "2250051",
          "3021841051",
          "3002806809",
          "3003741796",
          "3012240236",
          "1827821",
          "3000148879",
          "3002806559",
          "2517506",
          "3004445302",
          "3006769061",
          "1000136573",
          "3005333358",
          "3010825766",
          "2432235",
          "3007662974",
          "1000122044"
        ],
        "device_name": "Lipase-Esterase, Enzymatic, Photometric, Lipase",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1465",
        "device_class": "1"
      }
    }
  ]
}