Biofire Defense recalls

Recall found. Biofire Defense is named in FDA Class II recall Z-2877-2026 covering FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code. 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. Status: Ongoing.

Models with recalls

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code (1)

All Biofire Defense recalls

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 …

Official ID Z-2877-2026 · Official record ↗

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