Recall Z-2877-2026

Reason for recall

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.

FDA-determined cause: Under Investigation by firm

Action taken

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.