Health product recall

Biofire® Filmarray® Gastrointestinal (Gi) Panel

Last updated

Summary

Product
Biofire® Filmarray® Gastrointestinal (Gi) Panel
Issue
Medical devices - Performance issue
What to do

Contact Biomérieux for additional assistance or questions. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Biofire® Filmarray® Gastrointestinal (Gi) Panel All lots. RFIT-ASY-0116 RFIT-ASY-0104

Issue

Biomérieux has identified a potential signal of increased false positive norovirus results when using the Biofire® Filmarray® Gastrointestinal (Gi) Panel. All unexpired product is potentially impacted.

Recall start date: February 2, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies

Biofire Diagnostics, LLC.

515 Colorow Dr., Salt Lake City, Utah, United States, 84108

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75057