Biofire Defense recalled 130 kits of the FilmArray NGDS Warrior Panel on July 10, 2025. The recall is due to an increased risk of internal control failures when testing positive blood cultures. These failures could delay results and require additional diagnostic workups.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Biofire Defense or your healthcare provider for instructions. Notification method: Letter
The FilmArray NGDS Warrior Panel (NGDS-ASY-0007) is a multiplexed, nucleic acid-based diagnostic test designed for use with the FilmArray 2.0 system. It is classified as a Class II medical device and has been distributed nationwide across multiple states.
There is an increased risk of internal control failures when using the FilmArray NGDS Warrior Panel for positive blood culture testing. This may lead to delays in diagnosis and treatment.
Currently, there are no specific incident reports or injury counts related to this recall, but the potential for delayed diagnosis poses a significant health risk.
Patients and healthcare providers should stop using the FilmArray NGDS Warrior Panel immediately. Follow the recall instructions provided by Biofire Defense and contact your healthcare provider for further guidance.
For more information, contact Biofire Defense or visit the recall notice at the FDA's website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2609-2025.
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