Class II

Medical Device Recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

BioFire Diagnostics, LLC · April 1, 2026

Reason for Recall

Respiratory/sore throat panel test may result in false negative results and control failures.

Distribution

US Nationwide distribution in the states of MS, TX MN, VA.

States Affected

NATIONWIDE

Quantity Affected

2400 pouches

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2081-2026

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.