{
  "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": "184071",
      "product_res_number": "Z-0402-2021",
      "event_date_initiated": "2020-10-08",
      "event_date_created": "2020-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-11-03",
      "res_event_number": "86574",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.",
      "code_info": "Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1  UDI: 20845357040446",
      "firm_fei_number": "2150138",
      "recalling_firm": "Microbiologics Inc",
      "address_1": "200 Cooper Ave N",
      "city": "Saint Cloud",
      "state": "MN",
      "postal_code": "56303-4440",
      "additional_info_contact": "Emily Dunaisky\n320-229-7073",
      "reason_for_recall": "Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Communication was extended to consignees that received product directly from the recalling firm.  Distributors outside of the United States will be contacted via email, and if follow-up is required, the recalling firm's international sales team will contact the distributor to ensure that this communication is extended to their end-users.\nThe recalling firm will work with the European Authorized Representative to coordinate all field safety corrective actions for consignees in the EU.\nThe recalling firm will conduct effectiveness checks by contacting 100% of consignees that do not respond to the correspondence.  This will be completed via phone or email.",
      "product_quantity": "46 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.",
      "openfda": {
        "k_number": [
          "K822954",
          "K820064",
          "K855198",
          "K861022",
          "K831653",
          "K812698",
          "K842579",
          "K862914",
          "K821660",
          "K842129",
          "K830133",
          "K871121"
        ],
        "registration_number": [
          "2150138",
          "3006091463",
          "2518630",
          "1924669",
          "2030538",
          "2436875",
          "9610649",
          "1050138",
          "3015715780"
        ],
        "fei_number": [
          "2150138",
          "3006091463",
          "2518630",
          "1924669",
          "1050138",
          "1000521444",
          "3002807578",
          "1000520007",
          "3015715780"
        ],
        "device_name": "Kit, Quality Control For Culture Media",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2480",
        "device_class": "1"
      }
    }
  ]
}