{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191401",
      "product_res_number": "Z-0581-2022",
      "event_date_initiated": "2020-10-08",
      "event_date_created": "2022-02-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-07-07",
      "res_event_number": "89386",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)",
      "code_info": "Catalog Number : 0318P,  Lot Number: 318-234-4,  UDI: 20845357006213",
      "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": "The incorrect lot number was printed on the foil pouch that the KWIK-STIK\" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK\" canister label and KWIK-STIK\" device label.",
      "root_cause_description": "Employee error",
      "action": "Microbiologics notified customers on about 10/08/2020 via letter titled \"Urgent Medical Device Recall.\" Instructions included to inspect inventory for affected products. If found, instructions included the following: \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 orrecall@microbiologics.com.",
      "product_quantity": "187 units",
      "distribution_pattern": "US distribution to .\n\nInternational distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam",
      "openfda": {
        "k_number": [
          "K842129",
          "K830133",
          "K821660",
          "K820064",
          "K842579",
          "K812698",
          "K831653",
          "K855198",
          "K862914",
          "K871121",
          "K861022",
          "K822954"
        ],
        "device_name": "Kit, Quality Control For Culture Media",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2480",
        "device_class": "1",
        "registration_number": [
          "3006091463",
          "2518630",
          "1050138",
          "3015715780",
          "2030538",
          "1924669",
          "9610649",
          "2150138",
          "2436875"
        ],
        "fei_number": [
          "3006091463",
          "2518630",
          "1050138",
          "3015715780",
          "1000520007",
          "3002807578",
          "1000521444",
          "2150138",
          "1924669"
        ]
      }
    }
  ]
}