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Biofire® filmarray® pneumonia (pnplus) panel plus
Official notice
15 Aug 2025
Last checked
15 Aug 2025
An official Health Canada notice concerns Biofire® filmarray® pneumonia (pnplus) panel plus. 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 Published 2025-08-15.
What to do now
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
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Brand: Biofire Diagnostics, Biofire® Filmarray® Pneumonia Panel Plus.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
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