BioFire FilmArray Pneumonia Panel recall in Canada: Performance issue
In plain language
This recall involves BioFire FilmArray Pneumonia (PNplus) Panels sold in Canada. It's being recalled because of a performance issue that could lead to false positive results for seasonal coronavirus. Healthcare professionals should stop using the product and contact the importer for instructions.
What to do
- ["Stop using the product immediately.","Contact the importer for further instructions."]
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Affected products
BioFire® FilmArray® Pneumonia (PNplus) Panel Plus
Model: RFIT-ASY-0142, RFIT-ASY-0143
Lot: All lots
Why this matters
Performance issue leading to false positive results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: RFIT-ASY-0142, RFIT-ASY-0143
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue leading to false positive results
What should consumers do?
["Stop using the product immediately.","Contact the importer for further instructions."]
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue leading to false positive results
When was this product recalled?
This product was recalled on August 15, 2025.
Is the Biofire Diagnostics, LLC. brand affected by this recall?
Yes, Biofire Diagnostics, LLC. products are affected by this recall. This recall involves BioFire FilmArray Pneumonia (PNplus) Panels sold in Canada. It's being recalled because of a performance issue that could lead to false positive results for seasonal coronavirus. Healthcare professionals should stop using the product and contact the importer for instructions.