{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Toronto",
      "state": "",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83472",
      "recalling_firm": "Luminex Molecular Diagnostics",
      "address_1": "439 University Ave Suite 900",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution to CA, CT, MA, and PA    OUS: None",
      "recall_number": "Z-0161-2020",
      "product_description": "xTAG Respiratory Viral Panel (RVP):  Box Label:  xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111     in vitro diagnostic test",
      "product_quantity": "56 Kits",
      "reason_for_recall": "The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.",
      "recall_initiation_date": "20190716",
      "center_classification_date": "20191018",
      "report_date": "20191030",
      "code_info": "Catalogue Number:I019C0111  Device UDI: 00840487100462  Lot Numbers:  IK019C-0129   IK019C-0130   IK019C-0131   IK019C-0132",
      "more_code_info": ""
    }
  ]
}