CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report
FilmArray Ngds Warrior Panel Ngds-asy-0007 is a qualitative recalled
Biofire Defense is recalling FilmArray Ngds Warrior Panel Ngds-asy-0007 is a qualitative, multiplexed, nucleic, distributed nationwide in the US. The recall was initiated on 10 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2609-2025
- FDA event ID
- 97286
- Recalling firm
- Biofire Defense, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jul 2025
- FDA classified
- 19 Sep 2025
- Reported
- 1 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Jul 2025 | Recall initiated by company | |
| 19 Sep 2025 | Classified by FDA | +71 days |
| 1 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaDistrict of ColumbiaFloridaHawaiiIowaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew HampshireNevadaNew YorkOhioRhode Island
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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)
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biofire Defense
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FilmArray NGDS Warrior Panel recalled by Biofire Defense | Biofire Defense | Device Malfunction | Nationwide |
| Device | CLASS III | FilmArray NGDS Warrior Panel recalled by Biofire Defense | Biofire Defense | Other | 6 states |
| Device | CLASS III | Jbaids Instrument System recalled by Biofire Defense | Biofire Defense | Device Malfunction | Nationwide |
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