BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box
Brand(s)
Last updated
Summary
Product
BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box
Issue
Medical devices - Performance
What to do
Contact the importer, bioMérieux Canada.
Audience
Healthcare
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Biofire Diagnostics, Llc.
515 Colorow Dr., Salt Lake City, Utah, United States, 84108
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75985
Get notified
Receive notifications for new and updated recalls and alerts by category.