{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "193521",
      "product_res_number": "Z-1334-2022",
      "event_date_initiated": "2022-06-17",
      "event_date_created": "2022-07-06",
      "recall_status": "Open, Classified",
      "res_event_number": "90122",
      "product_code": "OZN",
      "product_description": "Verigene CDF Nucleic Acid Test, Part No. 30-002-22",
      "code_info": "UDI 00840487101735\nLuminex Lot Number 042021022D, FLOQ Swab Lot Numbers:  2100856, 2032870; \nLuminex Lot Number 071321022F, FLOQ Swab Lot Numbers:  2100856, 2107946; \nLuminex Lot Number 100421022A, FLOQ Swab Lot Numbers:  2110850; \nLuminex Lot Number 110221022E, FLOQ Swab Lot Numbers:  2107946.",
      "firm_fei_number": "3006028115",
      "recalling_firm": "Luminex Corporation",
      "address_1": "4088 Commercial Ave",
      "city": "Northbrook",
      "state": "IL",
      "postal_code": "60062-1829",
      "additional_info_contact": "847-400-9000 Ext. 9029",
      "reason_for_recall": "There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm notified its consignees of the recall by letter on 06/17/2022.  The letter explained the issue and provided the following actions be taken:\n\"Customer Action:\n1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal.\n2. If you currently have any of the identified affected VERIGENE Stool Sample Preparation Kits in your possession (reference Tables 1 & 2 for impacted kit lots), please contact Luminex Global Support Services at support@luminexcorp.com to arrange for replacement and confirm the disposal of any remaining kits in your inventory per the package insert disposal guidelines.\n3. Perform a retrospective review of results for VERIGENE Enteric Pathogens Nucleic Acid test and VERIGENE CDF Nucleic Acid test from 3/25/2021 to11/29/2021. If you have encountered a false negative result with a patient sample tested with kits received during this time frame, please contact Luminex Global Support Services at support@luminexcorp.com\n4. Distribute the notification to any individuals within your organization who need to be made aware of this recall.\n5. Please complete the  Acknowledgement & Receipt Form  and return it to Luminex Technical Support.\n6. For those with complaints, questions, or concerns, please contact Luminex Global Support Services at 1-877-785-2323 (U.S. and Canada) or +1-512-381-4397 (Outside U.S. and Canada).\n7. Reports can also be made directly to the FDA MedWatch Serious Injury Reporting Program online by completing and submitting the report online at: www.fda.gov/medwatch/report, or by regular mail or Fax:  Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.\"",
      "product_quantity": "296 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.",
      "openfda": {
        "k_number": [
          "K212427",
          "K171770",
          "K142422",
          "K123998",
          "K163085",
          "K243730",
          "K260045",
          "K123355",
          "K130470",
          "K210385",
          "K123197",
          "K132235",
          "K133936",
          "K132726",
          "K172569",
          "K171441",
          "K170491",
          "K232092"
        ],
        "device_name": "C. Difficile Toxin Gene Amplification Assay",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3130",
        "device_class": "2",
        "registration_number": [
          "3012494290",
          "3012918440",
          "1119779",
          "3004013603",
          "3004141078",
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          "9610126",
          "2243471"
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          "3012918440",
          "1119779",
          "3004013603",
          "3004141078",
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        ]
      }
    }
  ]
}