Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative

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.

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

• FDA enforcement recordOfficial FDA database entry for Z-2609-2025
• 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.