{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214816",
      "product_res_number": "Z-2265-2025",
      "event_date_initiated": "2025-06-04",
      "event_date_posted": "2025-08-04",
      "recall_status": "Open, Classified",
      "res_event_number": "97196",
      "product_code": "CDX",
      "product_description": "Brand Name: T4 Total ELISA\nProduct Name: T4 Total ELISA\nModel/Catalog Number: EIA-4568\nProduct Description: T4 Total ELISA",
      "code_info": "Model/Catalog Number: EIA-4568;\nUDI-DI: 04048474045680;\nLot number: 304K034;",
      "firm_fei_number": "2245285",
      "recalling_firm": "DRG International, Inc.",
      "address_1": "841 Mountain Ave",
      "city": "Springfield",
      "state": "NJ",
      "postal_code": "07081-3437",
      "additional_info_contact": "Ina Hairston (US Agent for DRG Instruments)\nUS-973-5647555",
      "reason_for_recall": "An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).",
      "root_cause_description": "Reprocessing Controls",
      "action": "On June 4, 2025 FIELD SAFETY NOTICE letters were sent to customers.\nAction to be taken by distributors and end-users:\nPlease check your inventory for the respective lot. Please use the CoA provided with this FSN. If you require corrected outer kit box label for your documentation, please contact DRG. If you have transferred any of the affected products to another laboratory, please provide them with a copy of this letter.\nIf you have any questions concerning this issue, please do not hesitate to contact us.",
      "product_quantity": "47 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, MA, PA and the countries of  Germany, Hong Kong, Moldova.",
      "openfda": {
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          "K840852",
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          "K830642",
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          "K934384",
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          "K770474",
          "K760227",
          "K782103",
          "K943416",
          "K780707",
          "K860421",
          "K870573",
          "K772096",
          "K921935",
          "K782109",
          "K770676",
          "K780854",
          "K801105",
          "K780672",
          "K933426",
          "K823004",
          "K772330",
          "K770726",
          "K901475",
          "K883559",
          "K931295",
          "K864560",
          "K791231"
        ],
        "registration_number": [
          "3017379203",
          "3017894300",
          "3009984016",
          "1219913",
          "3017019647",
          "3002800697",
          "2245285",
          "9610126",
          "8043909",
          "3009335633",
          "2032839",
          "2432235",
          "3003741796"
        ],
        "fei_number": [
          "3002806559",
          "3017379203",
          "3009984016",
          "3017894300",
          "1219913",
          "3017019647",
          "3004185580",
          "3002800697",
          "2245285",
          "3002808498",
          "3009335633",
          "2432235",
          "3003741796"
        ],
        "device_name": "Radioimmunoassay, Total Thyroxine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1700",
        "device_class": "2"
      }
    }
  ]
}