FilmArray® NGDS Warrior Panel
Brand(s)
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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