BioFire FilmArray instruments recall in Canada: Performance issue
In plain language
This recall involves BioFire FilmArray 2.0 Instruments and BioFire FilmArray Torch Module Boxes sold in Canada. They are being recalled because a calibration issue may cause inaccurate test results. Stop using the product and contact the importer for re-calibration.
What to do
- Stop using the product immediately.
- Contact bioMérieux Canada for re-calibration.
- Check model numbers FLM2-ASY-0001 and HTFA-SUB-0103.
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Affected products
BioFire® FilmArray® 2.0 Instruments
Model: FLM2-ASY-0001
Lot: More than 10 numbers, contact manufacturer.
BioFire® FilmArray® Torch Module Box
Model: HTFA-SUB-0103
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Inaccurate test results due to calibration issue
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: FLM2-ASY-0001, HTFA-SUB-0103
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?
Inaccurate test results due to calibration issue
What should consumers do?
Stop using the product immediately. Contact bioMérieux Canada for re-calibration. Check model numbers FLM2-ASY-0001 and HTFA-SUB-0103.
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. Inaccurate test results due to calibration issue
When was this product recalled?
This product was recalled on August 29, 2024.
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 2.0 Instruments and BioFire FilmArray Torch Module Boxes sold in Canada. They are being recalled because a calibration issue may cause inaccurate test results. Stop using the product and contact the importer for re-calibration.