{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "188611",
      "product_res_number": "Z-2451-2021",
      "event_date_initiated": "2021-08-03",
      "event_date_created": "2021-09-10",
      "recall_status": "Open, Classified",
      "res_event_number": "88423",
      "product_code": "PCH",
      "k_numbers": [
        "K140083"
      ],
      "product_description": "Verigene EP Amplification Reagent Kit Test",
      "code_info": "Model: Verigene Enteric Pathogens (EP) Stool PREP KIT; Catalog Number: 30-002-023;\nLots:  111620023A\n010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D\n022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A, 112320023B, 120120023D, 120120023E, 120220023D, 120220023E, 120720023A, 120720023B, 120720023C, 120720023D, 120920023D, 120920023E, 120920023F, 121420023B, 121420023C, 121520023D, 121520023E, 121620023D, 121620023E, 122120023A, 122120023B,, 122220023D, 122220023E, 122820023A, 122820023B, 122920023D, 122920023E, 122920023F",
      "firm_fei_number": "3006028115",
      "recalling_firm": "Luminex Corporation",
      "address_1": "4088 Commercial Ave",
      "city": "Northbrook",
      "state": "IL",
      "postal_code": "60062-1829",
      "additional_info_contact": "847-400-9115",
      "reason_for_recall": "There is potential for false positive results.",
      "root_cause_description": "Process control",
      "action": "A customer letter was issued to notify consignees of the recall dated 08/03/2021.  Customers are advised to notify Luminex if they are impacted by the recall and Luminex will facilitate replacement of the product.  Customers are asked to destroy impacted product and document actions on a return response form.",
      "product_quantity": "4579 kits",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.",
      "openfda": {
        "k_number": [
          "K243885",
          "K142033",
          "K254032",
          "K251868",
          "K140647",
          "K243813",
          "K152955",
          "K220062",
          "K220193",
          "K140083",
          "K252329",
          "K181427",
          "K191161",
          "K253722",
          "K251993",
          "K121894",
          "K230404",
          "K242877",
          "K123274",
          "K190585",
          "K232672",
          "K143005",
          "K160459",
          "K183030",
          "K251721",
          "K242367",
          "K143648",
          "DEN130003",
          "K140407",
          "K182703",
          "K142501",
          "K180041",
          "K250324",
          "K191160",
          "K170308",
          "K220607",
          "K140377",
          "K183023"
        ],
        "registration_number": [
          "3004530258",
          "3007799234",
          "1119779",
          "3002773840",
          "3014553740",
          "3002777243",
          "3007420875",
          "3005360469",
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          "3010749841",
          "3016838963",
          "3009613136",
          "2024800",
          "3006028115",
          "1650733",
          "3004013603"
        ],
        "fei_number": [
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          "1119779",
          "3002773840",
          "3014553740",
          "3002777243",
          "3007420875",
          "3011781554",
          "3010749841",
          "3016838963",
          "3009613136",
          "3002524000",
          "3005670738",
          "2024800",
          "3006028115",
          "3004013603"
        ],
        "device_name": "Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3990",
        "device_class": "2"
      }
    }
  ]
}