BioFire Diagnostics, LLC Recalls

3 recalls on record in the United States

medical: 3
medical Class II
2026-05-13

BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 t

Contamination to in-vitro diagnostic test may result in false positives.

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medical Class II
2026-05-13

BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

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

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medical Class II
2026-08-19

BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code:

Due to increase in false negative results

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