BIOFIRE® Filmarray® Gastrointestinal (GI) Panel
Brand(s)
Summary
Contact the importer, Biomérieux Canada Inc.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
BIOFIRE® Filmarray® Gastrointestinal (GI) Panel |
782425 |
RFIT-ASY-0116 |
Issue
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
Additional information
Details
Biofire Diagnostics, Llc.
515 Colorow Dr., Salt Lake City, Utah, United States, 84108
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