# Major Recall Alert: BioFire® FilmArray® Pneumonia (PNplus) Panel Plus Recalled Due to False Positive Risk for Seasonal Coronavirus
Biomérieux has initiated a significant product recall for their **BioFire® FilmArray® Pneumonia (PNplus) Panel Plus**. The recall, effective **August 7, 2025**, stems from an identified issue causing **false positive results for seasonal coronavirus**. This error is attributed to **non-specific amplification** or **cross-reactivity with high concentrations of human genomic DNA (hgDNA)** in clinical specimens. The problem appears exclusive to the PNplus panel configuration, as **other BioFire® respiratory panels remain unaffected.**
Keep reading to learn why this recall matters, the risks involved, and steps you should take if affected.
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## Why This Recall is Important
Accurate diagnostic testing is critical, particularly for respiratory illnesses like coronavirus. False positive results could lead to **mismanagement of patient care**, unnecessary testing, or unwarranted treatments. Biomérieux flagged this potential issue after uncovering that **non-specific interaction with hgDNA** could interfere with accurate seasonal coronavirus detection.
### Key Points About the Recall:
- **Brand and Product**: BioFire® FilmArray® Pneumonia (PNplus) Panel Plus only.
- **Start Date**: August 7, 2025.
- **Recall Reason**: False positive risk due to cross-reactivity with human genomic DNA at high concentrations.
- **Scope**: Exclusive to PNplus panel configuration; no issues reported for other BioFire® respiratory panels.
For healthcare providers and labs, this announcement is a reminder of the importance of ensuring diagnostic tools in use are fully reliable.
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## Details of the Recall
The specific issue identified involves incorrect detection of **seasonal coronavirus**, caused by **non-specific amplification** of human genomic DNA (hgDNA) in clinical specimens. This flaw may be encountered when **hgDNA concentrations are high**, causing cross-reactivity and inaccurate test results.
However, it is essential to note that **other BioFire® respiratory panels**, including those for broader respiratory pathogen detection, have shown **no evidence** of similar issues. The critical focus should remain on the **PNplus Panel configuration**.
If your facility uses the BioFire® PNplus Panel, it’s crucial to reassess test results already interpreted and avoid continued usage until Biomérieux offers further guidance.
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## What You Should Do
If you are a healthcare provider, lab technician, or affected user of the **BioFire® FilmArray® Pneumonia (PNplus) Panel Plus**, follow these steps:
- **Stop Usage Immediately**: Discontinue using the affected lot of panels.
- **Review Recent Results**: Carefully re-evaluate any positive results from tests conducted with this panel to rule out potential false positives.
- **Contact Biomérieux**: For more information or support, reach out to Biomérieux directly.
- **Regular Updates**: Monitor official sources for recall updates and resolutions. Visit the [official Canadian recall notice page](https://recalls-rappels.canada.ca/en/alert-recall/biofirer-filmarrayr-pneumonia-pnplus-panel-plus) for the latest information.
Healthcare organizations are encouraged to remain vigilant and confirm the reliability of all diagnostic tools in use.
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## Stay Safe – Get Instant Recall Alerts
Product recalls like this one for the **BioFire® FilmArray® Pneumonia (PNplus) Panel Plus** highlight the importance of staying informed. Don’t miss any critical safety notices—download the [Official Recall App](#) today to receive **real-time alerts** about product recalls, safety updates, and more.
By staying proactive, you can help protect patients, ensure accurate diagnostics, and prevent unnecessary risks.
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For more details about this important recall, visit the **official Canadian recall notice** [here](https://recalls-rappels.canada.ca/en/alert-recall/biofirer-filmarrayr-pneumonia-pnplus-panel-plus). Stay safe, take action promptly, and ensure your diagnostic practices remain secure and reliable.