Public recall detail

BIOFIRE® Filmarray® Gastrointestinal (GI) Panel

2024-07-18

medium
Recall Safety notice
Quick summary

Quick summary: BIOFIRE® Filmarray® Gastrointestinal (GI) Panel. Date: 2024-07-18.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: BIOFIRE® Filmarray® Gastrointestinal (GI) Panel. Date: 2024-07-18.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBiofire Diagnostics, LLC.
ProductBIOFIRE® Filmarray® Gastrointestinal (GI) Panel
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-75827

Affected products

ProductBIOFIRE® Filmarray® Gastrointestinal (GI) Panel
Lot782425 712258 743930 742049 769240
ModelRFIT-ASY-0116 RFIT-ASY-0104
Serial number782425 712258 743930 742049 769240
DescriptionBIOFIRE® Filmarray® Gastrointestinal (GI) Panel

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

What you should do

  • Contact the importer, Biomérieux Canada Inc.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Microbiology
CompaniesBiofire Diagnostics, Llc. 515 Colorow Dr., Salt Lake City, Utah, United States, 84108
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75827
Background{}
CompaniesBiofire Diagnostics, Llc. 515 Colorow Dr., Salt Lake City, Utah, United States, 84108
AudiencesHealthcare
Source updated2024-07-18

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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