Public recall detail

BioFire® FilmArray® Pneumonia (PNplus) Panel Plus

2025-08-15

medium
Recall Safety notice
Quick summary

Quick summary: BioFire® FilmArray® Pneumonia (PNplus) Panel Plus . Date: 2025-08-15.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: BioFire® FilmArray® Pneumonia (PNplus) Panel Plus . Date: 2025-08-15.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBiofire Diagnostics, LLC.
ProductBioFire® FilmArray® Pneumonia (PNplus) Panel Plus
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77922

Affected products

ProductBioFire® FilmArray® Pneumonia (PNplus) Panel Plus
LotAll lots.
ModelRFIT-ASY-0143
Serial numberAll lots.
DescriptionBioFire® FilmArray® Pneumonia (PNplus) Panel Plus
ProductBioFire® FilmArray® Pneumonia (PNplus) Panel Plus
LotAll lots.
ModelRFIT-ASY-0142
Serial numberAll lots.
DescriptionBioFire® FilmArray® Pneumonia (PNplus) Panel Plus

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

What you should do

  • Contact the importer.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Microbiology
CompaniesBiofire Diagnostics, LLC. 515 Colorow Dr., Salt Lake City, Utah, United States, 84108
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77922
Background{}
CompaniesBiofire Diagnostics, LLC. 515 Colorow Dr., Salt Lake City, Utah, United States, 84108
AudiencesHealthcare
Source updated2025-08-15

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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