{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "49406",
      "product_res_number": "Z-0454-2007",
      "event_date_initiated": "2006-09-26",
      "event_date_posted": "2007-01-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-06-14",
      "res_event_number": "36821",
      "product_code": "DLZ",
      "k_numbers": [
        "K993031"
      ],
      "product_description": "Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division",
      "code_info": "39074HW00 (exp. 9/30/06), 41008HW00 (exp. 10/31/06), 42063HW00 (exp. 12/31/06)",
      "firm_fei_number": "2018433",
      "recalling_firm": "Abbott Laboratories Inc.",
      "address_1": "820 Mission St",
      "city": "South Pasadena",
      "state": "CA",
      "postal_code": "91030-3142",
      "additional_info_contact": "Irene Powers\n847-937-1998",
      "reason_for_recall": "Erratic elevated results and or the inability to calibrate due to imprecision.",
      "root_cause_description": "Other",
      "action": "Abbott sent out a product recall letter on 9/26, 2006, to all consignees that received lot numbers 39074HW00, 41008HW00 and 42063HW00.  The letter states that the firm has identified a Phenobarbital performance issue that is demonstrated by erratic elevated results and/or the inability to calibrate due to imprecision. Until the cause of this issue is identified, they have discontinued shipment of Phenobarbital reagent. It will be necessary to identity an alternate means for Phenobarbital testing during this time. AXSYM and TDxITDxFLx Phenobarbital are available as alternate testing options (consignee may contact the local sales person or Customer Service).  Consignees also advised if they forwarded any of the Clinical Chemistry Phenobarbital lots listed above to another laboratory to provide a copy of the letter to their customer.  If there are questions, they are advised to call Customer Service (US consignee) or local sales person (foreign consignee).  \n\nLetter advises if user currently using or have inventory of lot number 39074HW00, expiration 9/30/06, to run two levels of quality control (QC) every 6 hours and be alert to QC trends.  For those using or have inventory  of lot numbers 41008HW00 & 42063HW00, they are advised to discontinue use of these lots and destroy them following laboratory procedures.  Abbott will provide reimbursement for the destroyed kits.  A customer reply form is provided.",
      "product_quantity": "Worldwide: Lot #41008HW00 - 162 kits; Lot #42063HW00 - 136 kits; Lot #39074HW00 - 150 Kits",
      "distribution_pattern": "Worldwide distribution ---- USA and countries of of Canada, Chile, Germany, Australia",
      "openfda": {
        "k_number": [
          "K802039",
          "K833796",
          "K984288",
          "K811621",
          "K852995",
          "K842264",
          "K071644",
          "K860046",
          "K943981",
          "K770919",
          "K860365",
          "K913190",
          "K811367",
          "K874625",
          "K935568",
          "K864926",
          "K910355",
          "K942501",
          "K946210",
          "K210858",
          "K854607",
          "K944932",
          "K993031",
          "K884419",
          "K852946",
          "K834216",
          "K011528",
          "K011303",
          "K832457",
          "K896861",
          "K862308",
          "K081231",
          "K832097",
          "K123271",
          "K000012"
        ],
        "registration_number": [
          "1219913",
          "3006198300",
          "2050012",
          "9610126",
          "3002642396",
          "3003561301",
          "3000308930",
          "2050010",
          "1319436",
          "3005333358",
          "3010825766",
          "9680746",
          "1319681",
          "1181121",
          "3011989923",
          "3010939897",
          "3003871639",
          "2432235",
          "3012963943",
          "2517506",
          "3002809144",
          "3004493545",
          "3003795116",
          "1319809",
          "9610529"
        ],
        "fei_number": [
          "1219913",
          "3002806560",
          "1000206808",
          "3002806559",
          "3006198300",
          "1000120319",
          "3002642396",
          "3003561301",
          "3000308930",
          "2050010",
          "3005333358",
          "3010825766",
          "1000305840",
          "3011989923",
          "1181121",
          "3010939897",
          "3003871639",
          "2432235",
          "3012963943",
          "2517506",
          "3002809144",
          "3004493545",
          "3003795116",
          "1000136573",
          "2050012"
        ],
        "device_name": "Enzyme Immunoassay, Phenobarbital",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3660",
        "device_class": "2"
      }
    }
  ]
}