{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221599",
      "product_res_number": "Z-2877-2026",
      "event_date_initiated": "2026-07-16",
      "event_date_posted": "2026-08-04",
      "recall_status": "Open, Classified",
      "res_event_number": "99459",
      "product_code": "PRD",
      "k_numbers": [
        "K170883"
      ],
      "product_description": "FilmArray NGDS Warrior Panel REF NGDS-ASY-0007\nUDI-DI code: (01)00851458005136\n\nThe FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).",
      "code_info": "Part Number: NGDS-ASY-0007\nUDI-DI code: (01)00851458005136\nLot Numbers:\n311825D\n312025D\n313526D\n322925D",
      "firm_fei_number": "3010770794",
      "recalling_firm": "Biofire Defense",
      "address_1": "79 W 4500 S Ste 14 79 W 4500 S",
      "address_2": "Ste 14",
      "city": "Salt Lake City",
      "state": "UT",
      "postal_code": "84107-2663",
      "additional_info_contact": "Customer Support\n801-262-3592 Ext. 3",
      "reason_for_recall": "Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 07/16/2026, an \"ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION\" Letter was sent via FedEx Priority Overnight to customer informing them that, due to the emergence of the 2026 Bundibugyo outbreak strain, BioFire Defense has conducted testing to evaluate performance of the Orthoebolavirus spp. assays on the FilmArray NGDS Warrior Panel. This preliminary testing has identified a potential reduction in sensitivity to the 2026 Bundibugyo outbreak strain which could result in Orthoebolavirus spp.  Not Detected  results when testing on the FilmArray NGDS Warrior Panel.\n\nCustomers are instructed to:\n\" Distribute this letter and the updated IFU (revision 5) to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product including others to whom you may have transferred FilmArray NGDS Warrior Panel product. Please follow applicable ITAR protocols for distribution.\n\" Train and ensure awareness by laboratory personnel on the  Additional Information and Required Actions  included in the updated IFU (Table 6, Pg. 24).\n\" Complete the Acknowledgement of Receipt. The web form can be found here: https://go.biofiredefense.com/FSCA-2601-Warrior-potential-ebola-not-detected-US or fill out the accompanying document.\n\nFor Questions - contact BioFire Defense Customer Technical Support at Support@BioFireDefense.com or via telephone at 1-801-262-3592.",
      "product_quantity": "122 kits (3,660 pouches)",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.",
      "openfda": {
        "k_number": [
          "DEN160048",
          "K170883",
          "K243822"
        ],
        "registration_number": [
          "3010770794"
        ],
        "fei_number": [
          "3010770794"
        ]
      }
    }
  ]
}