Recall MonitorHealth Products
BioFire® FilmArray® Pneumonia (PNplus) Panel Plus
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Microbiology
Product: BioFire® FilmArray® Pneumonia (PNplus) Panel Plus
Issue: Medical devices - Performance
What to do: Contact the importer.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| BioFire® FilmArray® Pneumonia (PNplus) Panel Plus | All lots. | RFIT-ASY-0143 |
| BioFire® FilmArray® Pneumonia (PNplus) Panel Plus | All lots. | RFIT-ASY-0142 |
Issue
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