{
  "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": "191473",
      "product_res_number": "Z-0584-2022",
      "event_date_initiated": "2020-10-01",
      "event_date_created": "2022-02-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-07-07",
      "res_event_number": "89391",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "QC Sets and Panels: KWIK-STIK\" 2 Pack.  Common Name: QC Sets and Panels GP Comprehensive QC Set.  \n\nEach KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2.",
      "code_info": "Catalog Number: 5193P;  \nLot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021);  \nUDI: 70845357030718",
      "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 contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Microbiologics notified customers on about 10/01/2020 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\ninformation 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\nrecords; \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": "11 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, FRANCE, GEORGIA, GERMANY, GUATAMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, 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"
        ]
      }
    }
  ]
}