BioFire Diagnostics, LLC
3
Recalls
0
Units Recalled
0
Injuries
0
Deaths
Categories: Medical Device
2026-05-13 to 2026-08-19
| Date | Source | Product | Brand | Severity | Units |
|---|---|---|---|---|---|
| 2026-08-19 | FDA Device | FDA Recall: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed | BioFire Diagnostics, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | BioFire Diagnostics, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 | BioFire Diagnostics, LLC | Class II | N/A |