⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Is BioFire Diagnostics recalled?

BioFire Diagnostics recalls - full list & free alerts

Official U.S. agency records list 4 recalls involving BioFire Diagnostics in the last 12 months, most recently on 2026-08-19. Check each official notice for the exact products, lot codes and dates affected.

Check a lot code, UPC or model number

This is not a guarantee; check the official notice.

Recalls (4)

BioFire Diagnostics, LLC: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Medical DevicesFDA (device) · 2026-08-19 · Class II
BioFire Diagnostics, LLC: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Medical DevicesFDA (device) · 2026-05-13 · Class II
BioFire Diagnostics, LLC: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Medical DevicesFDA (device) · 2026-05-13 · Class II
BioFire Diagnostics, LLC: BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Medical DevicesFDA (device) · 2025-12-03 · Class II
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