{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222503",
      "product_res_number": "Z-0082-2027",
      "event_date_initiated": "2026-07-02",
      "event_date_posted": "2026-10-02",
      "recall_status": "Open, Classified",
      "res_event_number": "99799",
      "product_code": "DFQ",
      "product_description": "Sperm Ab ELISA;\r\nModel/Catalog Number: EIA-1826;\r\nProduct Description: Sperm Ab ELISA (96 well plate test);",
      "code_info": "Model/Catalog Number: EIA-1826;\nUDI: 04048474018264;\nLot# 320K046;",
      "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)\n973-5647555",
      "reason_for_recall": "Potential for false negative patient results.",
      "root_cause_description": "Reprocessing Controls",
      "action": "On July 2, 2026 Field Safety Notice letters were sent to customers.\nActions to be taken:\nPlease check your stocks for the lot in question (320K046), stop using these kits immediately\nand quarantine these products without delay. Please destroy the kits and send us the\nconfirmation with the completed response form. If you have transferred any of the affected\nproducts to another laboratory, please provide them with a copy of this letter.",
      "product_quantity": "211",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.",
      "openfda": {
        "registration_number": [
          "3008987086",
          "3038206980",
          "2245285",
          "3009585529",
          "3030648160",
          "3038560224",
          "2025606",
          "3016837106",
          "3043127699",
          "3002800697",
          "3009335633"
        ],
        "fei_number": [
          "3008987086",
          "3038206980",
          "2245285",
          "3009585529",
          "3030648160",
          "3038560224",
          "2025606",
          "3016837106",
          "3043127699",
          "3002800697",
          "3009335633"
        ],
        "device_name": "Sperm, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5800",
        "device_class": "1"
      }
    }
  ]
}