Health product recall

FilmArray® NGDS Warrior Panel

Brand(s)
Biofire Defense Llc
Last updated

Summary

Product
FilmArray® NGDS Warrior Panel
Issue
Medical devices - Performance
What to do

Manufacturer will notify affected customers with instructions to follow. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

FilmArray® NGDS Warrior Panel

325425D

DFA2-ASY-0012

FilmArray® NGDS Warrior Panel

324725D

DFA2-ASY-0012

FilmArray® NGDS Warrior Panel

325925D

DFA2-ASY-0012

FilmArray® NGDS Warrior Panel

306626D

DFA2-ASY-0012

FilmArray® NGDS Warrior Panel

324325D

DFA2-ASY-0012

FilmArray® NGDS Warrior Panel

325825D

DFA2-ASY-0012

Issue

Testing has identified a potential reduction in sensitivity to the 2026 Bundibugyo outbreak strain which could result in Orthoebolavirus SPP. 'not detected' results when testing on the FilmArray® NGDS Warrior Panel - ca.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Biofire Defense Llc
79 West 4500 South, Salt Lake City, Utah, United States, 84107
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82440

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Date modified: