CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
FilmArray NGDS Warrior Panel recalled by Biofire Defense
Biofire Defense is recalling FilmArray NGDS Warrior Panel, distributed nationwide in the US. The recall was initiated on 16 Jul 2026 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-2877-2026
- FDA event ID
- 99459
- Recalling firm
- Biofire Defense, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jul 2026
- FDA classified
- 4 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Jul 2026 | Recall initiated by company | |
| 4 Aug 2026 | Classified by FDA | +19 days |
| 12 Aug 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The 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).
Where it was distributed
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.
Nationwide AlabamaCaliforniaDistrict of ColumbiaFloridaGeorgiaHawaiiKentuckyLouisianaMassachusettsMarylandMinnesotaNorth CarolinaNew HampshireNevadaNew YorkOhioRhode IslandTennesseeTexasUtah
Questions about this recall
Is FilmArray NGDS Warrior Panel recalled?
Yes. Biofire Defense recalled FilmArray NGDS Warrior Panel on 16 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-2877-2026.
Why was it recalled?
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.
Which lots are affected?
Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
Where was it sold?
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.
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 21 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 Ngds-asy-0007 is a qualitative recalled | Biofire Defense | Lead & Heavy Metals | 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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