Biofire Defense FilmArray NGDS Warrior Panel Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Biofire Defense is recalling 122 kits of the FilmArray NGDS Warrior Panel due to mismatches between outbreak and reference strains.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Biofire Defense has initiated a recall because the firm 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 Products Are Affected
The affected product is the FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 with UDI-DI code (01)00851458005136. Part Number: NGDS-ASY-0007. Lot Numbers: 311825D, 312025D, 313526D, 322925D. A total of 122 kits (3,660 pouches) are affected. Distribution was nationwide in the U.S. 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 You Should Do
Consumers should refer to the recall notice for further guidance on affected lots.
Why This Matters
The recall involves a Class II device distributed across multiple states for detection of pathogens including Bacillus anthracis and Ebola virus from human whole blood.
Source
FDA recall number Z-2877-2026. Event ID 99459.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,021 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.