{
  "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": "30624",
      "product_res_number": "Z-0324-04",
      "event_date_initiated": "2003-11-17",
      "event_date_posted": "2004-01-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-11-02",
      "res_event_number": "27843",
      "product_code": "LFH",
      "k_numbers": [
        "K833113"
      ],
      "product_description": "ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064",
      "code_info": "Product List number:  9681-55.",
      "firm_fei_number": "2623532",
      "recalling_firm": "Abbott Health Products, Inc.",
      "address_1": "Hwy 2 Km 58.0",
      "city": "Barceloneta",
      "postal_code": "00617",
      "country": "PR",
      "additional_info_contact": "Nydia I. Cancel\n787-846-8256",
      "reason_for_recall": "Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.",
      "root_cause_description": "Other",
      "action": "The Important Information Letter dated 11/17/03 was mailed to all ADx, TDx/TDxFL and AxSYM TCA reagent customers. The letters were sent to customers by Federal express Priority mail. The letter recommended contacting all customers who have received the reagents within the last 15 months.",
      "distribution_pattern": "Distribution was nationwide.",
      "openfda": {
        "k_number": [
          "K213875",
          "K983268",
          "K953761",
          "K961393",
          "K231020",
          "K981801"
        ],
        "device_name": "U.V. Spectrometry, Tricyclic Antidepressant Drugs",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3910",
        "device_class": "2",
        "registration_number": [
          "",
          "2517506",
          "2030633",
          "3005333358",
          "2246703",
          "3010939897"
        ],
        "fei_number": [
          "",
          "2517506",
          "3000210620",
          "3005333358",
          "2246703",
          "3010939897"
        ]
      }
    }
  ]
}