Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The…

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

On 07/16/2026, an "ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION" Letter was sent via FedEx Priority Overnight to customer informing them that, due to the emergence of the 2026 Bundibugyo outbreak strain, BioFire Defense has conducted testing to evaluate performance of the Orthoebolavirus spp. assays on the FilmArray NGDS Warrior Panel. This preliminary 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. Customers are instructed to: " Distribute this letter and the updated IFU (revision 5) to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product including others to whom you may have transferred FilmArray NGDS Warrior Panel product. Please follow applicable ITAR protocols for distribution. " Train and ensure awareness by laboratory personnel on the Additional Information and Required Actions included in the updated IFU (Table 6, Pg. 24). " Complete the Acknowledgement of Receipt. The web form can be found here: https://go.biofiredefense.com/FSCA-2601-Warrior-potential-ebola-not-detected-US or fill out the accompanying document. For Questions - contact BioFire Defense Customer Technical Support at Support@BioFireDefense.com or via telephone at 1-801-262-3592.

• FDA enforcement recordOfficial FDA database entry for Z-2877-2026
• FDA 510(k) clearance · K170883The device's official FDA premarket clearance record
• FDA device classification · PRDOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Biofire DefenseSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.