FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: recall status

Notice names this product. Biofire Defense’s FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code is named in FDA Class II recall Z-2877-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D. Units affected: 122 kits (3,660 pouches). Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code
Company / brand: Biofire Defense
Lot / serial / date codes: Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
Distribution: 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.

Agency product description and boundaries

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).

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Biofire Defense

Recalls naming this model

FDA Class II · Medical device · August 12, 2026

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code recall — Biofire Defense

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 …

Company / brand: Biofire Defense

Affected product: FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code

Official ID Z-2877-2026 · Official record ↗

See all Biofire Defense recalls →

Verify with the official sources:

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.