Biomérieux has identified an increased risk for false positive detection of seasonal coronavirus due to non-specific amplification or cross-reactivity with high concentrations of human genomic DNA (hgDNA) that could be present in clinical specimens. This non-specific interaction with hgDNA is solely observed in the assay configuration found in the BioFire® PNplus panels and has not been replicated in other BioFire® respiratory panels. Recall start date: August 7, 2025
RecallTracker