Health Canada — Medical Devices · Canada · 2024-08-29 · Type II
As described by Health Canada — Medical Devices: BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box
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Reported risk: 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
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