{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "217581",
      "product_res_number": "Z-0984-2026",
      "event_date_initiated": "2025-12-02",
      "event_date_posted": "2025-12-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98079",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P",
      "code_info": "UDI-DI: 20845357006459;\nLot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5",
      "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": "Rebecca Neu\n320-229-7080",
      "reason_for_recall": "Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Medical Device Recall notification letter was sent to customers on 12/2/25.\n\nINSTRUCTIONS:\n1. REVIEW lab procedures to understand how this information 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. NOTIFY other facilities or customers to whom the product may have been distributed or transferred.\n7. CONTACT Microbiologics if a replacement kit is needed.\n\nMicrobiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team\n\nAn Urgent Medical Device Recall dated 12/22/25 was sent to customers. \n\nINSTRUCTIONS:\n1. REVIEW lab procedures to understand how this information 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. NOTIFY other facilities or customers to whom the product may have been distributed or transferred.\n7. CONTACT Microbiologics if a replacement kit is needed.\nMicrobiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.",
      "product_quantity": "86 units (127 additional units 12/22/25)",
      "distribution_pattern": "Worldwide - US Nationwide.",
      "openfda": {
        "k_number": [
          "K812698",
          "K871121",
          "K822954",
          "K855198",
          "K831653",
          "K842579",
          "K820064",
          "K862914",
          "K842129",
          "K830133",
          "K821660",
          "K861022"
        ],
        "device_name": "Kit, Quality Control For Culture Media",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2480",
        "device_class": "1",
        "registration_number": [
          "9610649",
          "2436875",
          "3015715780",
          "3006091463",
          "1924669",
          "1050138",
          "2150138",
          "2030538",
          "2518630"
        ],
        "fei_number": [
          "1000520007",
          "3015715780",
          "3006091463",
          "1924669",
          "1050138",
          "2150138",
          "2518630",
          "3002807578",
          "1000521444"
        ]
      }
    }
  ]
}