{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
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      "cfres_id": "190381",
      "product_res_number": "Z-0920-2022",
      "event_date_initiated": "2019-04-22",
      "event_date_created": "2022-04-13",
      "recall_status": "Open, Classified",
      "res_event_number": "89051",
      "product_code": "NSU",
      "product_description": "Verigene Processor SP, Model Numbers:  10-0000-07 and 10-0000-07-R",
      "code_info": "Model Number 10-0000-07, Serial Numbers:  13042054,16347082,17215010;   Model Number 10-0000-07-R, Serial Numbers: 18079010",
      "firm_fei_number": "3006028115",
      "recalling_firm": "Luminex Corporation",
      "address_1": "4088 Commercial Ave",
      "city": "Northbrook",
      "state": "IL",
      "postal_code": "60062-1829",
      "reason_for_recall": "Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm sent technicians to sites beginning on 13 March 2019 to test the devices and the devices were subsequently returned.  The firm send a notice regarding the recall on 03/10/2022 by email.  The notices documented the actions of the firm with respect to the devices.",
      "product_quantity": "4 units",
      "distribution_pattern": "US:  TX, CT, LA",
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        "device_name": "Instrumentation For Clinical Multiplex Test Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
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    }
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}