Class 2 Device Recall FilmArray NGDS Warrior Panel

• Date Initiated by Firm: July 16, 2026
• Date Posted: August 04, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2877-2026
• Recall Event ID: 99459
• 510(K)Number: K170883
• Product Classification: Biothreat microbial agents multiplex nucleic acid detection system - Product Code PRD
• Product: FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).
• Code Information: Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D
• FEI Number: 3010770794
• Recalling Firm/ Manufacturer: Biofire Defense; 79 W 4500 S Ste 14; Salt Lake City UT 84107-2663
• For Additional Information Contact: Customer Support; 801-262-3592 Ext. 3
• Manufacturer 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: 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.
• Quantity in Commerce: 122 kits (3,660 pouches)
• Distribution: U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PRD