BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box
Brand(s)
Summary
Contact the importer, bioMérieux Canada.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
BioFire® FilmArray® 2.0 Instruments |
More than 10 numbers, contact manufacturer. |
FLM2-ASY-0001 |
BioFire® FilmArray® Torch Module Box |
More than 10 numbers, contact manufacturer. |
HTFA-SUB-0103 |
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
Additional information
Details
Biofire Diagnostics, Llc.
515 Colorow Dr., Salt Lake City, Utah, United States, 84108
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