bioMérieux warns of false positive KPC results on BioFire pneumonia and joint infection panels
The manufacturer has flagged an increased risk of false positive KPC resistance gene results on certain kit lots of three BIOFIRE panels, according to Dutch inspectorate IGJ.
bioMérieux has identified an increased risk of false positive results for the Klebsiella pneumoniae carbapenemase (KPC) antimicrobial resistance gene marker on certain kit lots of three BIOFIRE products. The affected products are the BIOFIRE FILMARRAY Pneumonia (PN) Panel, the BIOFIRE FILMARRAY Pneumonia plus (PNplus) Panel and the BIOFIRE Joint Infection (JI) Panel. The Dutch healthcare inspectorate IGJ has published the warning.
The specific lots concerned are listed in Appendix A of the manufacturer's letter. The IGJ page links to a four-page English-language PDF of the field safety notice (FSN), which is dated 15 September 2026. The IGJ listing carries the date 11 November 2026.
BioFire Diagnostics, LLC is named as the manufacturer, with bioMérieux SA as its authorised representative. The IGJ entry itself names the PN Panel plus and the JI Panel as the products. The notice text, however, also covers the PN Panel.
As general context, a field safety notice is the formal communication a manufacturer must send to users and the competent authority when post-market monitoring shows a risk that requires action. The IGJ page repeats this obligation but does not summarise the specific corrective actions in the manufacturer's letter.
What it means for your team
- Laboratories using the three BIOFIRE panels should check their kit lots against Appendix A of the field safety notice.
- Quality teams should read the full FSN for the manufacturer's instructions, since the IGJ page does not detail the corrective actions.
- Regulatory and vigilance staff should note that the FSN is dated 15 September 2026, while the IGJ listing is dated 11 November 2026.
- Users should be aware that a false positive KPC marker could lead to incorrect clinical interpretation, as flagged in the notice.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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