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Official recall record

BIOFIRE® Filmarray® Gastrointestinal (GI) Panel

Health Canada — Medical Devices · 2024-07-18 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-07-18
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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