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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