FDA Class II · Medical device · August 19, 2026
BIOFIRE Respiratory Panel 2 recall — BioFire Diagnostics, LLC
Due to increase in false negative results
Official ID Z-2936-2026 · Official record ↗
BioFire Diagnostics recalls
3 recent recalls on record for BioFire Diagnostics in connected official government data as of September 7, 2026 at 6:00 AM UTC.
Models with recalls
BIOFIRE Respiratory Panel 2 (1)BioFire Joint Infection (JI) Panel REF (1)Biofire Spotfire Respiratory/Sore Throat Panel REF (1)
All BioFire Diagnostics recalls
FDA Class II · Medical device · May 13, 2026
Biofire Spotfire Respiratory/Sore Throat Panel REF recall — BioFire Diagnostics, LLC
Respiratory/sore throat panel test may result in false negative results and control failures.
Official ID Z-2081-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
BioFire Joint Infection (JI) Panel REF recall — BioFire Diagnostics, LLC
Contamination to in-vitro diagnostic test may result in false positives.
Official ID Z-2067-2026 · Official record ↗
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.