Official recall record
BioFire® FilmArray® Pneumonia (PNplus) Panel Plus
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-08-15
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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