company
BioFire Diagnostics, LLC
Jurisdiction: US
FDA Warning Letter timeline
V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.
- fda_recall · device_recall2026-05-13BioFire Diagnostics, LLC — Class II recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- fda_recall · device_recall2026-05-13BioFire Diagnostics, LLC — Class II recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Frequently asked questions
- How many FDA warning letters has BioFire Diagnostics, LLC received?
- Argus HQ has not recorded an FDA warning letter for BioFire Diagnostics, LLC in our current dataset.
- What FDA recalls has BioFire Diagnostics, LLC issued?
- Argus HQ has recorded 2 FDA recalls tied to BioFire Diagnostics, LLC.
- Is BioFire Diagnostics, LLC FDA compliant?
- Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 2 recalls, and 0 approval records for BioFire Diagnostics, LLC. Review the linked FDA source records directly before drawing a compliance conclusion.
Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.