{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191370",
      "product_res_number": "Z-0543-2022",
      "event_date_initiated": "2021-02-24",
      "event_date_posted": "2022-01-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-07-11",
      "res_event_number": "89379",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P.  Packaged 2 units per pack.  IVD controls.",
      "code_info": "Catalog Number: 0726P, \nLot Number: 726-57-10, \nUDI: 20845357017486",
      "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": "Becky Neu\n320-229-7073",
      "reason_for_recall": "Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Microbiologics notified customers on about 02/24/2021 via letter titled \"Urgent Medical Device Recall.\"  Instructions included to inspect inventory for affected products.  If found, instructions were to: \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. CONTACT Microbiologics if a replacement kit is needed.  \n\nQuestions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.",
      "product_quantity": "65 packs (130 units)",
      "distribution_pattern": "Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of  Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.",
      "openfda": {
        "k_number": [
          "K842579",
          "K821660",
          "K855198",
          "K820064",
          "K842129",
          "K862914",
          "K812698",
          "K861022",
          "K831653",
          "K822954",
          "K830133",
          "K871121"
        ],
        "device_name": "Kit, Quality Control For Culture Media",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2480",
        "device_class": "1",
        "registration_number": [
          "2518630",
          "2150138",
          "1050138",
          "2436875",
          "1924669",
          "3006091463",
          "2030538",
          "9610649",
          "3015715780"
        ],
        "fei_number": [
          "1000521444",
          "2518630",
          "2150138",
          "3002807578",
          "1050138",
          "1924669",
          "3006091463",
          "1000520007",
          "3015715780"
        ]
      }
    }
  ]
}