Medical device recalls Moderate risk

Biofire Spotfire Respiratory/Sore Throat Panel REF recalled over fire hazard

Recall date
April 1, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Recall number
Z-2081-2026
FDA classification
Class II
Brand / firm
BioFire Diagnostics, LLC
Sold / distributed
US Nationwide distribution in the states of MS, TX MN, VA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

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