{
  "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": "191501",
      "product_res_number": "Z-0636-2022",
      "event_date_initiated": "2017-03-02",
      "event_date_created": "2022-02-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-04-22",
      "res_event_number": "89412",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus.  \n\nEach KWIK-STIK\" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK\" catalog number ending in  P  is a duopak and contains two KWIKSTIK\" sticks.",
      "code_info": "Catalog Number: 0939P, \nLot Number: 939-47-2, \nUDI: 20845357022701",
      "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": "Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.",
      "root_cause_description": "Labeling False and Misleading",
      "action": "Microbiologics notified customers on about 03/02/2017, via letter titled \"Medical Device Recall.\"  Customers were instructed to: \n\n1.\tDO NOT USE any lot number 939-47-1 or 939-47-2 you may have in inventory. \n2.\tQUARANTINE or DISCARD the product to prevent further use.\n3.\tRETURN any remaining inventory you have of this product to Microbiologics via FED-EX though the use of FED-EX account number 355830926, and mark box  Attention: Technical Manager. \n4.\tAcknowledge your receipt of this information by completing the attached form and returning to Microbiologics by e-mailing to tsobania@microbiolgics.com or by faxing to 320.253.6250.",
      "product_quantity": "2 units",
      "distribution_pattern": "International distribution in the countries of Canada and Germany.",
      "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"
        ]
      }
    }
  ]
}