{
  "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": "191614",
      "product_res_number": "Z-0712-2022",
      "event_date_initiated": "2014-10-06",
      "event_date_created": "2022-03-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-01-17",
      "res_event_number": "89451",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "KWIK-STIK, Quality control kit for culture media, sold as: \n\na. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299\n\nb. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299",
      "code_info": "a. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-74-2 (10/08/2014), 959-74-3 (10/08/2014), 959-74-7 (10/08/2014), 959-75-4 (04/22/2015), 959-75-8 (04/22/2015), 959-75-9 (04/22/2015), 959-75-14 (04/22/2015), 959-76-1 (07/08/2015), 959-77-3 (10/21/2015); \n\nb. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-74-4 (10/08/2014), 959-74-6 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-8 (04/22/2015), 959-75-12 (04/22/2015), and 959-77-1 (10/21/2015)",
      "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": "This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Microbiologics notified customers on about 10/06/2014 via letter titled \"E.faecalis Gentamicin Susceptibility Notification.\" Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall, it is recommended that the intended use of the organism be reviewed to determine if Gentamicin synergy results have an impact on use. It is recommended to discard these lots if an impact is to be expected.\n\nQuestions or concerns can be directed to the Technical Support team at 320.229.7064 or techsupport@microbiologics.com.",
      "product_quantity": "1,873 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.",
      "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"
        ]
      }
    }
  ]
}