BIOFIRE® Joint Infection Panel – 30 Pack

Beginning April 5, 2026, elevated rates of KPC unexpected positives were observed in reagent final QC testing of the BIOFIRE® FILMARRAY® Pneumonia Panel, BIOFIRE® FILMARRAY® Pneumonia Panel Plus, and BIOFIRE® Joint Infection Panel, including in passing product that met final QC negativity requirements. Internal testing of failing product has reproduced KPC unexpected positive results, suggesting KPC nucleic acid (organism or synthetic) contamination in the pouch at levels that can lead to false positive results. Additional testing has confirmed that an isolated component, the outer primer pellet, is sufficient for producing unexpected positive KPC results.