{
  "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": "29368",
      "product_res_number": "Z-0165-04",
      "event_date_initiated": "2002-07-31",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-11-26",
      "res_event_number": "27178",
      "product_code": "DFT",
      "k_numbers": [
        "K982132"
      ],
      "product_description": "AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA",
      "code_info": "All lots",
      "firm_fei_number": "2018433",
      "recalling_firm": "Abbott Laboratories Diagnostic Div",
      "address_1": "820 Mission Street",
      "city": "South Pasadena",
      "state": "CA",
      "postal_code": "91030",
      "reason_for_recall": "Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.",
      "root_cause_description": "Other",
      "action": "Consignees were provided with assay parameters for the RCD flag which may enhance the detection of these type of specimens.  The assay parameter settings for the RCD flag were distributed to all AEROSET consignees in the United States by direct mail and to country managers worldwide via a Product Information letter dated July 31, 2002.  Also provided with the Product Information letter was an AEROSET IgM Application Sheet containing the updated assay parameters for the RCD flag.",
      "product_quantity": "205 units",
      "distribution_pattern": "Nationwide to the following states:  Texas, Illinois, Indiana, Tennessee, Alaska, Pennsylvania, New York, Florida, Massachusetts, Missouri, Alabama, North Carolina, California, Ohio, Utah, Michigan, Arizona, Wisconsin, Oklahoma, Maine, Kansas, Georgia, Mississippi, Connecticut, Rhode Island, Washington, Wyoming, Louisiana, Washington, Maryland, New Jersey, Arkansas, Iowa, South Carolina, Colorado, Minnesota, North Dakota, and West Virginia.  Worldwide to the following countries:  Argentina, Australia, Brazil, Germany, England, Canada, Chile, Colombia, Dominican Republic, Denmark, France, Hong Kong, Japan, Korea, Singapore, Guatemala, New Zealand, Thailand, Turkey, Spain, Italy, South Africa, Sweden, Greece, Portugal, Venezuela, Pakistan, Finland, Ireland, and Taiwan.",
      "openfda": {
        "k_number": [
          "K791402",
          "K831103",
          "K862762",
          "K871498",
          "K803251",
          "K873871",
          "K872237",
          "K894417",
          "K802177",
          "K811124",
          "K962201",
          "K760917",
          "K884147",
          "K853469",
          "K901453",
          "K945522",
          "K855010",
          "K760147",
          "K770963",
          "K830606",
          "K983132",
          "K842327",
          "K841814",
          "K955797",
          "K772254",
          "K800167",
          "K812632",
          "K831608",
          "K760673",
          "K880828",
          "K801282",
          "K832265",
          "K832259"
        ],
        "registration_number": [
          "3004493545",
          "2050010",
          "1000403749",
          "3002809144",
          "3016438761",
          "1181121",
          "3000148879",
          "3005094123",
          "3005333358",
          "2050012",
          "1618982"
        ],
        "fei_number": [
          "3004493545",
          "2050010",
          "1000403749",
          "3002809144",
          "3016438761",
          "1181121",
          "3000148879",
          "3005094123",
          "3005333358",
          "2050012",
          "1618982"
        ],
        "device_name": "Igm, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5550",
        "device_class": "2"
      }
    }
  ]
}