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Health Canada Medical devices

BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box

Issued August 29, 2024
Issue
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
Hazard description
Performance
Product
Product name
BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box
Reference
ID
RA-75985