FDA DeviceClass IINotable

FDA Recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Date: 2026-05-13
Brand: BioFire Diagnostics, LLC
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

2400 pouches

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