{
  "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": "191381",
      "product_res_number": "Z-0546-2022",
      "event_date_initiated": "2020-12-16",
      "event_date_created": "2022-01-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-01-12",
      "res_event_number": "89384",
      "product_code": "JTR",
      "k_numbers": [
        "K861022"
      ],
      "product_description": "KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U.  \n\nSpecifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)",
      "code_info": "Main Product Codes: Catalog Number: 8164, Lot Number: 8164-78, UDI: 70845357028623, Expiration date: 09/30/2021.\n\nAffected Component Codes: Catalog Number: 0243U, Lot Number: 243-48-5, UDI: 10845357004083, Expiration Date on Label: 07/31/2020, Correct Expiration Date: 07/31/2022.",
      "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": "The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.",
      "root_cause_description": "Employee error",
      "action": "Microbiologics notified customers on about 12/16/2020 via letter titled \"Urgent Medical Device Recall.\" Instructions included to inspect inventory for affected products. If found, instructions were to update records with the correct expiration date of 07/31/2022 and keep the letter for their records.\n\nQuestions or concerns can be directed to Recall Support team at\n320.229.7073 or recall@microbiologics.com.",
      "distribution_pattern": "US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.",
      "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"
        ]
      }
    }
  ]
}