{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "218748",
      "product_res_number": "Z-1586-2026",
      "event_date_initiated": "2026-02-18",
      "event_date_posted": "2026-03-19",
      "recall_status": "Open, Classified",
      "res_event_number": "98441",
      "product_code": "OYB",
      "pma_numbers": [
        "P100042"
      ],
      "product_description": "Brand Name: Aptima HPV Assay\nProduct Name: Aptima HPV Assay\nModel/Catalog Number: 303585\nProduct Description: Aptima HPV assay\nComponent: No",
      "code_info": "Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box:\n\nUDI Number for PN 302883: 15420045500051\nUDI Number for PN 302885: 15420045500068",
      "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": "Michael Watts\n1-858-4108514 Ext. 128",
      "reason_for_recall": "Due to product exhibiting potential to generate either invalid or false negative results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 02/18/2026, the firm sent via FedEx an \"URGENT: MEDICAL DEVICE RECALL NOTIFICATION\" letter to customers informing them that Hologic has identified that the Aptima HPV Assay kits from ML 929785 exhibit the potential to generate either invalid results for samples and calibrators or false negative results for low analyte samples when  reagents are not used on the day of reconstitution.\n\nCustomers are instructed:\n1. Discontinue use of the Aptima HPV Assay kits from ML 929785.\n2. Segregate and count the number of affected product on-hand and dispose according t the local guidelines and regulations.\n3.Fill out the Customer Response Form using the link https://iqvia-response.my.site.com/mt/fca?cid=hpv-929785\n4. Hologic will process and ship the replacement kits\n\nFor Questions or concerns, contact Hologic Technical Support at +1 888-484-4747 or +1 858-410-8511 during hours 5 am to 5 pm PT or by email at molecularsupport@hologic.com",
      "product_quantity": "306",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.",
      "openfda": {
        "pma_number": [
          "P100042",
          "P120007"
        ],
        "registration_number": [
          "2024800"
        ],
        "fei_number": [
          "2024800"
        ],
        "device_name": "Kit, Rna Detection, Human Papillomavirus",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}