{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "211026",
      "product_res_number": "Z-0694-2025",
      "event_date_initiated": "2024-11-08",
      "event_date_posted": "2024-12-20",
      "recall_status": "Open, Classified",
      "res_event_number": "95731",
      "product_code": "QOF",
      "k_numbers": [
        "K222736"
      ],
      "product_description": "Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400",
      "code_info": "UDI-DI: 15420045515352\n\nKit lot 892307, Expiration: May 15, 2025.\nCartridge Lot 890494",
      "firm_fei_number": "2024800",
      "recalling_firm": "Hologic, Inc.",
      "address_1": "10210 Genetic Center Dr",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4362",
      "additional_info_contact": "408-745-0975 Ext. 128",
      "reason_for_recall": "SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On 11/8/24, recall notices were mailed to customers asking them to do the following:\n\n1) Discontinue use, and discard affected kits.\n2) Complete and return the customer response firm via email to molecularsupport@hologic.com\n\nIf you require technical support, contact the firm's Technical Support at 1-888-484-4747, or 1-858-410-8511, or molecularsupport@hologic.com",
      "product_quantity": "3",
      "distribution_pattern": "US: AK",
      "openfda": {
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        ],
        "device_name": "Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3981",
        "device_class": "2"
      }
    }
  ]
}