{
  "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": "30604",
      "product_res_number": "Z-0318-04",
      "event_date_initiated": "2003-11-25",
      "event_date_posted": "2004-01-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-07-26",
      "res_event_number": "27834",
      "product_code": "LTK--",
      "k_numbers": [
        "K964020",
        "K964185"
      ],
      "product_description": "AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064",
      "code_info": "all lots",
      "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",
      "additional_info_contact": "Abbott Customer Support \n877-422-2688",
      "reason_for_recall": "The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4",
      "root_cause_description": "Other",
      "action": "Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents.  The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product.  The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls.",
      "distribution_pattern": "Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica, Japan, Korea, New Zealand, Pakistan, Puerto Rico, Singapore, Taiwan, Thailand, United Kingdom and Uruguay.",
      "openfda": {}
    }
  ]
}