{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "214716",
      "product_res_number": "Z-2194-2025",
      "event_date_initiated": "2025-06-27",
      "event_date_posted": "2025-07-29",
      "recall_status": "Open, Classified",
      "res_event_number": "97168",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as:  1) REF 0894K (6-pack), 2) REF 0894P (2-pack)",
      "code_info": "1) 0894K:  UDI/DI 30845357021954, Lot Numbers: 894-76-81; \n2) 0894P:  UDI/DI 20845357021940, Lot Numbers:  894-76-21, 894-76-51, 894-76-52.",
      "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": "Rebecca Neu\n320-229-7080",
      "reason_for_recall": "KWIK-STIK REF numbers:  0894P, 0894K and LYFO DISK\" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Microbiologics issued an Urgent Medical Device Recall notice on 06/27/2025 via email.  The notice explained the problem with the device, potential risk, and requested the following:  \nINSTRUCTIONS:\n1. REVIEW lab procedures to understand how this information affects your usage.  \n2. USE OR DISCARD depending on your lab procedures and how this information affects your usage.  \n3. COMPLETE the response form provided.  \n4. RETURN the response form to recall@microbiologics.com.  \n5. KEEP this letter for your records.  \n6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred.  \n7. CONTACT Microbiologics if a replacement kit is needed.  \nContact Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns.",
      "product_quantity": "32 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.",
      "openfda": {
        "k_number": [
          "K842129",
          "K821660",
          "K855198",
          "K842579",
          "K830133",
          "K862914",
          "K831653",
          "K812698",
          "K822954",
          "K871121",
          "K820064",
          "K861022"
        ],
        "registration_number": [
          "2030538",
          "3006091463",
          "1924669",
          "1050138",
          "2518630",
          "2150138",
          "9610649",
          "2436875",
          "3015715780"
        ],
        "fei_number": [
          "3002807578",
          "3006091463",
          "1924669",
          "1050138",
          "2518630",
          "1000520007",
          "2150138",
          "3015715780",
          "1000521444"
        ],
        "device_name": "Kit, Quality Control For Culture Media",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2480",
        "device_class": "1"
      }
    }
  ]
}