{
  "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": "31083",
      "product_res_number": "Z-0366-04",
      "event_date_initiated": "2003-12-16",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-07-20",
      "res_event_number": "27978",
      "product_code": "CGN--",
      "k_numbers": [
        "K972232"
      ],
      "product_description": "AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA",
      "code_info": "List 3C81-65, lot 06783M100",
      "firm_fei_number": "1415939",
      "recalling_firm": "Abbott Laboratories HPD/ADD/GPRD",
      "address_1": "100/200 Abbott Park Road",
      "city": "Abbott Park",
      "state": "IL",
      "postal_code": "60064",
      "reason_for_recall": "The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.",
      "root_cause_description": "Other",
      "action": "Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04.  Device recall letters dated 12/16/03 and 12/31/03 will be sent  to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components.  There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.",
      "product_quantity": "1,029 packs",
      "distribution_pattern": "There was no U.S. distribution.  The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.",
      "openfda": {}
    }
  ]
}