BioFire Diagnostics, LLC Recalls

6 recalls on record in the United States

medical: 6
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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medical Class II
2026-10-21

BioFire Diagnostics, LLC recalls Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Na

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

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medical Class II
2026-10-21

BioFire Diagnostics, LLC recalls Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name:

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

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medical Class II
2026-10-21

BioFire Diagnostics, LLC recalls Generic Name: FilmArray¿ Pneumonia Panel Generic Name: Film

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

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