Biofire® Filmarray® Gastrointestinal (Gi) Panel
Brand(s)
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 |
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
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