{
  "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": "183478",
      "product_res_number": "Z-0054-2021",
      "event_date_initiated": "2018-12-10",
      "event_date_created": "2020-10-05",
      "recall_status": "Open, Classified",
      "res_event_number": "86358",
      "product_code": "OCC",
      "k_numbers": [
        "K143653"
      ],
      "product_description": "VERIGENE Processor SP\nModel No. 10-0000-07.  An in vitro diagnostic device intended for processing and identifying nucleic acids",
      "code_info": "Catalogue Number:  10-0000-07 Serial No. 14230205 UDI Code: 00857573006010",
      "firm_fei_number": "3002524000",
      "recalling_firm": "Luminex Corporation",
      "address_1": "12212 Technology Blvd",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78727-6101",
      "additional_info_contact": "Wendy Ricker\n608-203-8936",
      "reason_for_recall": "No results/incorrect results due to failure of the hybridization heater.",
      "root_cause_description": "Component design/selection",
      "action": "On or about 11/19/2018 there was one complaint from a customer regarding a thermal control failure. In response to the complaint the Field Service Engineer replaced hybridization heater and ran all tests as passed. Subsequently, the customer reported the initial service was ineffective. The VERIGENE SP Processor was then removed from the customer site and returned for analysis.\n\nNo Customer Notification was communicated for this removal.",
      "product_quantity": "1 system",
      "distribution_pattern": "US distribution in MO.\n\nNo OUS",
      "openfda": {
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          "K142045",
          "K121003",
          "K103175",
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        ],
        "registration_number": [
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          "3021140368",
          "3019946577",
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        "fei_number": [
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          "3021140368",
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          "3002524000",
          "3038610665",
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          "3010749841",
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        ],
        "device_name": "Respiratory Virus Panel Nucleic Acid Assay System",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3980",
        "device_class": "2"
      }
    }
  ]
}