Salt Lake City, UT, US · 8 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | Class II | Microbiology | 2 | 2026-07-17 |
| QMV | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness | Class II | Microbiology | 2 | 2022-10-20 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | Class II | Microbiology | 2 | 2022-07-25 |
| PRD | — | — | — | 1 | 2025-03-12 |
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | Class II | Immunology | 1 | 2023-03-22 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-07-16 | Class II | Ongoing | Z-2877-2026 | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a… | — | Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based … |
| 2025-07-10 | Class II | Ongoing | Z-2609-2025 | FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test in… | — | FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed r… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-17 | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | PMN | Class II | Microbiology |
| 2025-03-12 | K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | PRD | — | — |
| 2023-03-22 | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | QVR | Class II | Immunology |
| 2022-10-20 | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | QMV | Class II | Microbiology |
| 2022-07-25 | K221460 | BioFire COVID-19 Test 2 | QQX | Class II | Microbiology |
| 2021-11-01 | K211079 | BioFire COVID-19 Test 2 | QQX | Class II | Microbiology |
| 2020-11-20 | K202382 | FilmArray Global Fever Panel External Control Kit | PMN | Class II | Microbiology |
| 2020-11-20 | DEN200043 | FilmArray Global Fever Panel | QMV | Class II | Microbiology |