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Medium severity

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateApril 01, 2026
ReportedMay 13, 2026
Recalling firmBioFire Diagnostics, LLC
Country / regionUnited States UT

Hazard

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

Affected products

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