{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "161541",
      "product_res_number": "Z-0924-2018",
      "event_date_initiated": "2017-11-10",
      "event_date_created": "2018-03-07",
      "recall_status": "Open, Classified",
      "res_event_number": "79181",
      "product_code": "MIU",
      "k_numbers": [
        "K023889"
      ],
      "product_description": "Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0\n\nDiagnosis of Chagas disease.",
      "code_info": "Product Code 1293254, Lot Code 1709228140",
      "firm_fei_number": "3001026625",
      "recalling_firm": "Wiener Laboratories",
      "address_1": "Street",
      "city": "Riobamba",
      "country": "Argentina",
      "additional_info_contact": "757-224-0177",
      "reason_for_recall": "Internal program testing shows that product may not reach the indicated expiration date.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On about November 10, 2017, customers were notified via email of the recall.  Instructions include to examine inventory and cease distribution of the device, make arrangements to return affected devices, acknowledge receipt of the recall notification, and notify customers if further distributed.",
      "product_quantity": "1,563 units",
      "distribution_pattern": "Worldwide Distribution -  US Distribution to the states of :  Florida and Washington DC.  , and to the countries of :   Argentina, Bolivia, Brasil, and Costa Rica.",
      "openfda": {
        "k_number": [
          "K930272",
          "K911233",
          "K023889",
          "K072732",
          "K933716",
          "K161947"
        ],
        "registration_number": [
          "1181055",
          "3026241718",
          "2029372",
          "3022178699",
          "2431980",
          "3026565854",
          "1319681",
          "8040374",
          "3032562",
          "2250051",
          "3043196750"
        ],
        "fei_number": [
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          "3026241718",
          "5864",
          "3022178699",
          "2431980",
          "3026565854",
          "1000136573",
          "1000306617",
          "3002606748",
          "2250051",
          "3043196750"
        ],
        "device_name": "Enzyme Linked Immunosorbent Assay, T. Cruzi",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3870",
        "device_class": "1"
      }
    }
  ]
}