{
  "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": "191497",
      "product_res_number": "Z-0587-2022",
      "event_date_initiated": "2020-02-18",
      "event_date_posted": "2022-02-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-07-11",
      "res_event_number": "89401",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set.  KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms",
      "code_info": "Catalog Number: 5112P; Lot Numbers: 5112-01 (Expiration Date 07/31/2020), 5112-02 (Expiration Date 10/31/2020); UDI: 70845357026551",
      "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": "Kali Sorum, RM(NRCM)\n320-229-7064",
      "reason_for_recall": "Tests returning incorrect susceptible results.  High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.",
      "root_cause_description": "Process design",
      "action": "Microbiologics notified customers on about 02/18/2020 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 thisinformation 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 Technical Support team at 320.229.7045 or recall@microbiologics.com.",
      "product_quantity": "10 units",
      "distribution_pattern": "Worldwide Distribution.  US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan,  Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and 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"
        ]
      }
    }
  ]
}