{
  "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": "43420",
      "product_res_number": "Z-0384-06",
      "event_date_initiated": "2005-11-10",
      "event_date_posted": "2006-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-03-20",
      "res_event_number": "34281",
      "product_code": "DFT",
      "k_numbers": [
        "K983132"
      ],
      "product_description": "Clinical Chemistry Immunoglobulin M, List Number 1E01-20",
      "code_info": "Lot Number(s): 30067HW00, 27057HW00, & 23026HW00",
      "firm_fei_number": "2018433",
      "recalling_firm": "Abbott Laboratories Diagnostic Div",
      "address_1": "820 Mission St",
      "city": "South Pasadena",
      "state": "CA",
      "postal_code": "91030-3142",
      "additional_info_contact": "Mark Littlefield\n972-518-6062",
      "reason_for_recall": "These specific protein assays are not meeting the 57-day on board stability claim",
      "root_cause_description": "Other",
      "action": "A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..",
      "product_quantity": "1275 (212 in US)",
      "distribution_pattern": "Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand",
      "openfda": {
        "k_number": [
          "K862762",
          "K760917",
          "K945522",
          "K800167",
          "K962201",
          "K832265",
          "K871498",
          "K811124",
          "K803251",
          "K760147",
          "K901453",
          "K855010",
          "K791402",
          "K880828",
          "K894417",
          "K872237",
          "K955797",
          "K853469",
          "K830606",
          "K772254",
          "K831608",
          "K832259",
          "K983132",
          "K873871",
          "K831103",
          "K802177",
          "K884147",
          "K842327",
          "K770963",
          "K841814",
          "K801282",
          "K760673",
          "K812632"
        ],
        "registration_number": [
          "2050012",
          "3005333358",
          "3004493545",
          "2050010",
          "3002809144",
          "3000148879",
          "1000403749",
          "1181121",
          "3005094123",
          "3016438761",
          "1618982"
        ],
        "fei_number": [
          "2050012",
          "3005333358",
          "3004493545",
          "2050010",
          "3002809144",
          "3000148879",
          "1000403749",
          "1181121",
          "3005094123",
          "3016438761",
          "1618982"
        ],
        "device_name": "Igm, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5550",
        "device_class": "2"
      }
    }
  ]
}