{
  "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": "203804",
      "product_res_number": "Z-0307-2024",
      "event_date_initiated": "2023-10-18",
      "event_date_posted": "2023-11-15",
      "recall_status": "Open, Classified",
      "res_event_number": "93267",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "KWIKSTIK, P. venetum, Catalog numbers:  a) 0794P (2-pack),  b) 0794K (6-pack)",
      "code_info": "a) UDI/DI 20845357019169, Lot Numbers:  794-142-2, 794-142-4\nb) UDI/DI 30845357019173, Lot Numbers:  794-142-3",
      "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": "A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Microbiologics issued an Urgent Medical Device Recall notice to its consignees on 10/18/2023 via email.  The notice explained the issue and requested that the labs review their procedures to understand who the issue affects its usage, use or discard  depending on its procedures, and contact Microbiologics if a replacement kit is needed.  \nFor questions or concerns contact the Recall Support team at 1.320.229.7073 or recall@microbiologics.com.",
      "product_quantity": "13 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.",
      "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": [
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          "2518630",
          "2150138",
          "3002807578",
          "1050138",
          "1924669",
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        ]
      }
    }
  ]
}