Class 2 Device Recall FilmArray NGDS Warrior Panel (NGDSASY0007)

• Date Initiated by Firm: July 10, 2025
• Date Posted: September 19, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2609-2025
• Recall Event ID: 97286
• 510(K)Number: K170883
• Product Classification: Biothreat microbial agents multiplex nucleic acid detection system - Product Code PRD
• Product: FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
• Code Information: UDI-DI: 00851458005136. Lot(Expiration): 324324D(2026-02-19), D241022(2026-01-22), 319524D(2025-11-20), 315424D(2025-10-09), 315224D(2025-10-03), 315324D(2025-10-08)
• 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
• Manufacturer Reason for Recall: FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
• FDA Determined Cause: Component design/selection
• Action: On 7/10/2025, correction notices were mailed and emailed to customers who were asked to do the following: - If testing with only whole blood and/or sputum, there is no impact to the product s performance. Continue using panel kits as planned. - If testing with positive blood culture may occur, discontinue use, dispose of impacted kit(s) according to your lab s procedures, and only use replacement kits provided, or use impacted lots only with whole blood and/or sputum sample types. - Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties who may use this product, including others to whom you may have transferred our product. - Complete and return the acknowledgment of receipt form via email to support@biofiredefense.com
• Quantity in Commerce: 130 Kits
• Distribution: US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, 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