{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Branchburg",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91482",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 Us Highway 202 S",
      "address_2": "",
      "postal_code": "08876-3733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution worldwide.",
      "recall_number": "Z-1104-2023",
      "product_description": "cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190",
      "product_quantity": "18,071 kits (US); 30,085 kits (OUS)",
      "reason_for_recall": "The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.",
      "recall_initiation_date": "20221221",
      "center_classification_date": "20230207",
      "report_date": "20230215",
      "code_info": "UDI-DI 00875197006674 All in-date lots",
      "more_code_info": ""
    }
  ]
}