FilmArray NGDS Warrior Panel (Biofire Defense) – Control Failure (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Biofire Defense
Lot Codes / Batch Numbers
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)
Products Sold
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)
Biofire Defense is recalling FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitr due to FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026