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Lower risk Medical device recall · FDA · Published July 10, 2025

Biofire Defense FilmArray NGDS Warrior Panel Recall: Risk of Delayed Test Results

Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 due to increased risk of internal control failures when testing positive blood cultures, potentially causing delayed results and extra diagnostic work.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2609-2025Medical deviceBiofire Defense ›
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Contact the company

Recalling firmBiofire Defense79 W 4500 S Ste 14 · Salt Lake City, UT 84107-2663
✎ GovInfoNow plain-language explainer

Biofire Defense is recalling its FilmArray NGDS Warrior Panel NGDS-ASY-0007 diagnostic test because it can fail internal controls when testing positive blood cultures, leading to delayed results and extra testing. This affects labs using the product for blood culture diagnostics. Read more at govinfonow.com/recall/51818-biofire-defense-filmarray-ngds-warrior-panel-recall-risk-of-delayed.

Source Summary by GovInfoNow · govinfonow.com/recall/51818-biofire-defense-filmarray-ngds-warrior-panel-recall-risk-of-delayed · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2609-2025

Cite this page

“Biofire Defense FilmArray NGDS Warrior Panel Recall: Risk of Delayed Test Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51818-biofire-defense-filmarray-ngds-warrior-panel-recall-risk-of-delayed. Based on FDA recall #Z-2609-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2609-2025%22&limit=1).

The FDA announced on July 10, 2025, that Biofire Defense is recalling FilmArray NGDS Warrior Panel (NGDS-ASY-0007) due to an increased risk of internal control failures when testing positive blood culture. This defect may lead to delayed results and additional diagnostic workup.

How to tell if you have it

  • Brand: Biofire Defense
  • Product: FilmArray NGDS Warrior Panel
  • Model/Lot: NGDS-ASY-0007
  • Lot Codes/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)
  • UDI-DI: 00851458005136
  • Quantity: 130 Kits
  • Distribution: US Nationwide in 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

The hazard

The FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture. This issue may lead to delayed results and additional diagnostic workup.

Context

GovInfoNow's records show Biofire Defense has two other recalls on record since August 20, 2019. On July 16, 2026, the firm recalled a FilmArray NGDS Warrior Panel due to an outbreak strain mismatch risk. On August 20, 2019, Biofire Defense recalled a FilmArray NGDS Warrior Panel for including an incorrect instruction for use revision. Other recent recalls of similar products include BioFire Joint Infection Panel Recall (April 22, 2026), BioFire Spotfire Respiratory Panel Recall (April 1, 2026), and BioFire Respiratory Panel 2.1 Recall (October 22, 2025).

How to tell if you have this one

Check for the model number NGDS-ASY-0007 on the panel. The product was sold with specific expiration dates listed in the recall notice.

  • Brand
    Biofire Defense
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number NGDS-ASY-0007 on the panel to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 24 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, District of Columbia, Florida, Hawaii, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New York, North Carolina, Ohio, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jul 10, 202512. FDA classified it Class II: Sep 19, 202523. Published in FDA’s Enforcement Report: Oct 1, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2609-2025 (July 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2609-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA