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Biofire Defense

4 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArr recall (Z-2877-2026)Biofire Defense2026-08-04
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-bas recall (Z-2609-2025)Biofire Defense2025-09-19
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only recall (Z-1448-2020)Biofire Defense2020-02-18
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable th recall (Z-2644-2014)Biofire Defense2014-09-15

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Every clearance here is in the API, with alerts when new ones post.