{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "169112",
      "product_res_number": "Z-0665-2019",
      "event_date_initiated": "2018-11-21",
      "event_date_created": "2018-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-01",
      "res_event_number": "81632",
      "product_code": "CEC",
      "k_numbers": [
        "K173122"
      ],
      "product_description": "Alinity i Free T4 Reagent Kit, List Number 07P7030",
      "code_info": "UDI/Lot Numbers (01)00380740121822 (17)190727(10)90111UI00 / 90111UI00 (01)00380740121822 (17)190911(10)92388UI00 / 92388UI00",
      "firm_fei_number": "3005094123",
      "recalling_firm": "Abbott Ireland Diagnostics Division",
      "address_1": "Lisnamuck",
      "city": "Lisnamuck Co. Longford",
      "country": "Ireland",
      "reason_for_recall": "Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A.  If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm initiated the recall by letter on 11/21/2018.  The notice explained the problem and provided instruction on how to inspect the reagent cartridges for defect.  The consignee was directed to discard the defective units.  The units will be replaced.",
      "product_quantity": "294 units",
      "distribution_pattern": "AR, FL, GA, MD, OK, VA",
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        "device_name": "Radioimmunoassay, Free Thyroxine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1695",
        "device_class": "2"
      }
    }
  ]
}