Class II

Medical Device Recall: BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

BioFire Diagnostics, LLC · October 22, 2025

Reason for Recall

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

Distribution

US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None

States Affected

AZ, FL, GA, ID, NC, NH, NJ, NY, OR, PA, SC

Quantity Affected

97 Kits (2,910 pouches)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0602-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.