{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "195023",
      "product_res_number": "Z-1398-2022",
      "event_date_initiated": "2022-07-12",
      "event_date_created": "2022-08-08",
      "recall_status": "Open, Classified",
      "res_event_number": "90602",
      "product_code": "QMC",
      "product_description": "HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type",
      "code_info": "No UDI. All lots distributed in the US.",
      "firm_fei_number": "3011676045",
      "recalling_firm": "Haimen Shengbang Laboratory Equipment Co. Ltd.",
      "address_1": "D, Sanhe D Sanhe No. 50 Xue Qian Road Sanhezhen Haimen",
      "city": "Nantong",
      "country": "China",
      "additional_info_contact": "Lei Fan\n86-189-38033981",
      "reason_for_recall": "Distributed VTM outside of VTM Guidance and without clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "The firm distributed a recall notification via email on 07/12/2022 dated 07/11/2022. This notification identifies the reason for recall to be that all vials of VTM distributed to the United States had not obtained 510K clearance and they weren't approved by FDA under the VTM Enforcement Policy. Customers are asked to identify any unused product and destroy it on-site. Additionally, testing institutions that have used product should evaluate previously obtained test results and evaluate the need to re-test patients. The firm has communicated they intend to apply to FDA for 510K clearance in the future for the recalled device. Customers with any questions are to conact Lei Fan at +86-18938033981 or market@hbxl.net.",
      "product_quantity": "8,710,600total units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CA, FL, IL & NY. The country of China.",
      "openfda": {
        "registration_number": [
          "3012389632",
          "3017830316",
          "3016741564",
          "3009963993",
          "3016884191",
          "3014588186",
          "3018779125",
          "8020040",
          "3010420046",
          "3014150341",
          "3015505238",
          "3003207991",
          "3005182159",
          "3013661582",
          "3009302820"
        ],
        "fei_number": [
          "3012389632",
          "3017830316",
          "3016741564",
          "3000974732",
          "3009963993",
          "3016884191",
          "3014588186",
          "3018779125",
          "3010420046",
          "3014150341",
          "3015505238",
          "3003207991",
          "3005182159",
          "3013661582",
          "3009302820"
        ],
        "device_name": "Transport Medium, Notified Per The Vtm Guidance",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2390",
        "device_class": "1"
      }
    }
  ]
}