Biofire Defense FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is aClass IIJul 16, 2026Firm has identified mismatches between the outbreak strain a	Firm has identified mismatches between the outbreak strain and the reference strain used in the development of	Class IIDevices	Jul 16, 2026
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test inClass IIJul 10, 2025FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increase	FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing p	Class IIDevices	Jul 10, 2025