{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191821",
      "product_res_number": "Z-0788-2022",
      "event_date_initiated": "2015-07-17",
      "event_date_created": "2022-03-16",
      "recall_status": "Completed",
      "res_event_number": "89513",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "LYFO Disk",
      "code_info": "Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)",
      "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": "Tina Sobania\n320-310-9217",
      "reason_for_recall": "LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Microbiologics notified customers on 07/17/2015 via letter titled \"Medical Device Recall\". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (LYFO DISK 0983L, Lot# 983-40-3), it is recommended that the customer destroys the product or return it to the recalling firm. Acknowledgement of the receipt of the recall letter was requested by completing a form and returning to Microbiologics.\n\nQuestions or concerns can be directed to the Quality Systems Manager at 320.229.7050.",
      "product_quantity": "3 units",
      "distribution_pattern": "Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.",
      "openfda": {
        "k_number": [
          "K862914",
          "K842129",
          "K822954",
          "K820064",
          "K812698",
          "K830133",
          "K871121",
          "K831653",
          "K855198",
          "K821660",
          "K842579",
          "K861022"
        ],
        "device_name": "Kit, Quality Control For Culture Media",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2480",
        "device_class": "1",
        "registration_number": [
          "2150138",
          "2030538",
          "2436875",
          "1050138",
          "3006091463",
          "9610649",
          "1924669",
          "3015715780",
          "2518630"
        ],
        "fei_number": [
          "2150138",
          "3002807578",
          "1050138",
          "3006091463",
          "1000520007",
          "1000521444",
          "1924669",
          "3015715780",
          "2518630"
        ]
      }
    }
  ]
}