BioFire® FilmArray® Pneumonia (PNplus) Panel Plus
Brand(s)
Last updated
Summary
Product
BioFire® FilmArray® Pneumonia (PNplus) Panel Plus
Issue
Medical devices - Performance
What to do
Contact the importer.
Audience
Healthcare
Affected 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Biofire Diagnostics, LLC.
515 Colorow Dr., Salt Lake City, Utah, United States, 84108
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77922
Get notified
Receive notifications for new and updated recalls and alerts by category.