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Biofire® filmarray® 2.0 instruments and biofire® filmarray® torch module box
Official notice
29 Aug 2024
Last checked
29 Aug 2024
An official Health Canada notice concerns Biofire® filmarray® 2.0 instruments and biofire® filmarray® torch module box. 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 Published 2024-08-29.
What to do now
Contact the importer, bioMérieux Canada.
Recall number
75985
Official notice
2024-08-29
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Biofire Diagnostics, Biofire® Filmarray® 2.0 Instruments And Biofire® Filmarray® Torch Module Box.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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