{
  "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": "196236",
      "product_res_number": "Z-0134-2023",
      "event_date_initiated": "2022-09-14",
      "event_date_posted": "2022-10-26",
      "recall_status": "Open, Classified",
      "res_event_number": "90937",
      "product_code": "QJR",
      "product_description": "ARIES SARS-CoV-2 Assay, REF: 50-10047",
      "code_info": "Lot - Expiration:  \nAB4723A - 05/25/2022,\nAB5041A - 05/25/2022,\nAB5060A - 06/01/2022,\nAB5061A - 06/06/2022,\nAB5081A - 06/07/2022,\nAB5139A - 09/10/2022,\nAB5141A - 09/16/2022,\nAB5263A - 09/27/2022,\nAB5282A - 10/05/2022,\nAB6640A - 06/8/2023,\nAB6720A - 06/13/2023",
      "firm_fei_number": "3002524000",
      "recalling_firm": "Luminex Corporation",
      "address_1": "12212 Technology Blvd",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78727-6101",
      "additional_info_contact": "512-219-8020",
      "reason_for_recall": "A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.",
      "root_cause_description": "Packaging process control",
      "action": "On 09/14/22, recall notices were emailed to customers who were asked to do the following: \n\n1. Cease all use, and isolate or quarantine affected devices pending disposal. \n2. If affected devices are identified, contact the recalling firm 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 obtained using the affected SARS-CoV-2 Assay.  If you suspect that you have encountered a false negative result\nwith a patient sample, please contact the recalling firm at support@luminexcorp.com. \n4. Distribute the notification to any individuals within your organization who need to be made aware of this recall. \n5. If affected devices were further distributed, notify your customers of this recall. \n6. Please complete and return the Acknowledgement & Receipt Form. \n7. For those with complaints, questions, or concerns, please contact Global Technical\nSupport Services at 1-877-785-2323 (U.S. and Canada) or +1-512-381 -4397 (Outside U.S. and Canada). \n\nOn 12/05/22, additional recall notices were sent to customers notifying them that two additional lots were impacted.",
      "product_quantity": "5,141 (24 Cassettes)",
      "distribution_pattern": "Distribution US nationwide, Indonesia, and Hong Kong.",
      "openfda": {
        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N",
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