Official recall record
BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-08-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Biomérieux has identified an issue with a subset of internal equipment used during the temperature calibration process on BioFire torch modules and 2.0 instruments manufactured or serviced since May 2022. The investigation found that BioFire instruments calibrated with this equipment may report higher melting temperatures (TMS). The impacted instruments must be returned to a BioFire service center for re-calibration. Recall Start Date: August 9, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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