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Biofire® filmarray® gastrointestinal (gi) panel
Official notice
18 Jul 2024
Last checked
18 Jul 2024
An official Health Canada notice concerns Biofire® filmarray® gastrointestinal (gi) panel. An increased number of customer complaints associated with Vibrio/Vibrio Cholerae false positive detections by the BIOFIRE Filmarray Gastrointestinal (GI) Panel have been observed when using Remel Cary-Blair transport medium. The BIOFIRE GI panel and the Cary-Blair transport medium are performing as intended. Per INV-19261, the root cause of the false positive Vibrio/Vibrio Cholerae results detected by the BIOFIRE GI panel is the presence of non-viable organism in the Remel Cary-Blair transport medium. Recall Start Date: July 4, 2024 Published 2024-07-18.
What to do now
Contact the importer, Biomérieux Canada Inc.
Recall number
75827
Official notice
2024-07-18
The hazard
The hazard
An increased number of customer complaints associated with Vibrio/Vibrio Cholerae false positive detections by the BIOFIRE Filmarray Gastrointestinal (GI) Panel have been observed when using Remel Cary-Blair transport medium. The BIOFIRE GI panel and the Cary-Blair transport medium are performing as intended. Per INV-19261, the root cause of the false positive Vibrio/Vibrio Cholerae results detected by the BIOFIRE GI panel is the presence of non-viable organism in the Remel Cary-Blair transport medium. Recall Start Date: July 4, 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.
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Affected products
Product 1
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
Manufacturer
Phone
Brand: Biofire Diagnostics, Biofire® Filmarray® Gastrointestinal Panel.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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