{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215069",
      "product_res_number": "Z-2609-2025",
      "event_date_initiated": "2025-07-10",
      "event_date_posted": "2025-09-19",
      "recall_status": "Open, Classified",
      "res_event_number": "97286",
      "product_code": "PRD",
      "k_numbers": [
        "K170883"
      ],
      "product_description": "FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.",
      "code_info": "UDI-DI: 00851458005136. Lot(Expiration): 324324D(2026-02-19), D241022(2026-01-22), 319524D(2025-11-20), 315424D(2025-10-09), 315224D(2025-10-03), 315324D(2025-10-08)",
      "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",
      "reason_for_recall": "FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.",
      "root_cause_description": "Component design/selection",
      "action": "On 7/10/2025, correction notices were mailed and emailed to customers who were asked to do the following:\n- If testing with only whole blood and/or sputum, there is no impact to the product s\nperformance. Continue using panel kits as planned.\n\n- If testing with positive blood culture may occur, discontinue use, dispose of impacted kit(s) according to your lab s procedures, and only use replacement kits provided, or use\nimpacted lots only with whole blood and/or sputum sample types.\n\n- Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties who may use this product, including others to whom you may have transferred our product.\n\n- Complete and return the acknowledgment of receipt form via email to support@biofiredefense.com",
      "product_quantity": "130 Kits",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, WA.",
      "openfda": {
        "k_number": [
          "K170883",
          "DEN160048",
          "K243822"
        ],
        "registration_number": [
          "3010770794"
        ],
        "fei_number": [
          "3010770794"
        ]
      }
    }
  ]
}