BioFire Diagnostics recalls

BioFire Diagnostics has 44 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 19 Aug 2026. 27 are still ongoing. 4 were reported in the last 12 months.

Total recalls44since 2014

Last 12 months4reported

Class I00% of total

Ongoing27latest 19 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 1 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 2 0 0Jul 1 0

Severity split

Class I 0 0%Class II 44 100%Class III 0 0%

Why biofire diagnostics is recalled

Product types

By year

202637%
202537%
20241227%
2023920%
2021818%
202037%
201925%
201837%
201412%

Ongoing biofire diagnostics recalls

27 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
13 May 2026Device	CLASS II	Biofire Spotfire Respiratory/Sore Throat Panel recalled	BioFire Diagnostics	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	BioFire Joint Infection (JI) Panel recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
3 Dec 2025Device	CLASS II	BioFire Respiratory Panel 1, IVD recalled by BioFire Diagnostics	BioFire Diagnostics	Device Malfunction	10 states
4 Jun 2025Device	CLASS II	BioFire Respiratory Panel 1 plus Kit recalled by BioFire Diagnostics	BioFire Diagnostics	Device Malfunction	Nationwide
16 Apr 2025Device	CLASS II	FilmArra Pneumonia Panel plus (Pneumoplus) recalled	BioFire Diagnostics	Device Malfunction	Nationwide

All biofire diagnostics recalls, newest first

44 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
13 May 2026Device	CLASS II	Biofire Spotfire Respiratory/Sore Throat Panel recalled	BioFire Diagnostics	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	BioFire Joint Infection (JI) Panel recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
3 Dec 2025Device	CLASS II	BioFire Respiratory Panel 1, IVD recalled by BioFire Diagnostics	BioFire Diagnostics	Device Malfunction	10 states
4 Jun 2025Device	CLASS II	BioFire Respiratory Panel 1 plus Kit recalled by BioFire Diagnostics	BioFire Diagnostics	Device Malfunction	Nationwide
16 Apr 2025Device	CLASS II	FilmArra Pneumonia Panel plus (Pneumoplus) recalled	BioFire Diagnostics	Device Malfunction	Nationwide
18 Sep 2024Device	CLASS II	Filmarray Torch Module, Htfa-asy-0003, Htfa-asy-0003-w recalled	BioFire Diagnostics	Salmonella	Nationwide
18 Sep 2024Device	CLASS II	Filmarray 0 Instrument recalled by BioFire Diagnostics	BioFire Diagnostics	Salmonella	Nationwide
28 Aug 2024Device	CLASS II	Biofire Filmarray Pneumonia Panel recalled by BioFire Diagnostics	BioFire Diagnostics	Lead & Heavy Metals	Nationwide
28 Aug 2024Device	CLASS II	Biofire Filmarray Pneumonia Panel plus recalled by BioFire Diagnostics	BioFire Diagnostics	Lead & Heavy Metals	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.