Biofire Defense
FDA Regulatory Profile
Biofire Defense appears in FDA public data with 3 recalls, 10 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2609-2025, Class II) was initiated on July 10, 2025. Its most recent 510(k) clearance was granted on July 17, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 10
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2609-2025 | Class II | FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitr | July 10, 2025 |
| Z-1448-2020 | Class III | FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only | August 20, 2019 |
| Z-2644-2014 | Class III | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocyc | August 13, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | July 17, 2026 |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | March 12, 2025 |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Feve | March 22, 2023 |
| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | October 20, 2022 |
| K221460 | BioFire COVID-19 Test 2 | July 25, 2022 |
| K211079 | BioFire COVID-19 Test 2 | November 1, 2021 |
| DEN200043 | FilmArray Global Fever Panel | November 20, 2020 |
| K202382 | FilmArray Global Fever Panel External Control Kit | November 20, 2020 |
| K170883 | FilmArray NGDS Warrior Panel | June 22, 2017 |
| DEN160048 | FilmArray NGDS Warrior Panel | February 14, 2017 |