Waters Corporation Achieves CE Mark for BD BACTEC FXI Culture System

The BD BACTEC FXI System is a fully automated blood culture system specifically designed to enhance the speed, consistency, and accuracy of bloodstream infection diagnostics. With its introduction, the system aims to address the critical need for timely diagnosis in patients suspected of bloodstream infections and sepsis—conditions that have significant implications for patient outcomes.

Clinical studies indicate that the BD BACTEC FXI System reduces the mean time to detection by approximately three hours, marking a 15% improvement over its predecessor, the BD BACTEC™ FX System. This expedited detection is essential, as research shows that sepsis-related deaths accounted for 31.5% of total global deaths in 2021. Moreover, every hour of delay in administering antibiotics significantly raises the risk of mortality, highlighting the importance of rapid diagnostics.

One of the key innovations of the BD BACTEC FXI System is its automated gravimetric measurement of blood culture vial volume. This groundbreaking capability addresses a common issue in clinical practice, where up to 85% of blood culture vials are filled inappropriately, negatively impacting diagnostic precision. By objectively confirming blood volume in each vial, the BD BACTEC FXI System diminishes pre-analytical variability, thereby enhancing diagnostic consistency and compliance with recommended collection practices.

Designed for high-throughput microbiology laboratories, the BD BACTEC FXI System features fully automated workflows that include vial loading, unloading, incubation, and detection alerts. Its capacity for automated loading of up to 60 vials at a time significantly reduces manual intervention, enabling laboratory staff to focus on more clinically relevant tasks. The system also offers flexibility, with modules that can accommodate 480 and 960 vials, making it suitable for laboratories of varying sizes.

Jianqing Bennett, Senior Vice President of Waters Advanced Diagnostics, emphasized the significance of the BD BACTEC FXI Culture System as a transformative advancement in automated microbiology. "This system combines speed, automation, and scalability, supporting laboratory modernization and addressing the growing global demand for efficient infectious disease testing," he stated.

In anticipation of the product launch and heightened market adoption, Waters Corporation has bolstered its manufacturing supply chain by diversifying its sourcing and strengthening supplier partnerships. This strategic move aims to enhance operational resilience while maintaining a strong commitment to quality and reliability in delivery.

Waters Corporation plans to showcase the BD BACTEC FXI System at the ESCMID Global 2026 conference in Munich, where live demonstrations will be conducted at Booth C60. The system is currently available in Europe and Japan, with the company actively pursuing regulatory clearances in other key global markets.

As Waters Corporation continues to innovate in the clinical diagnostics space, the introduction of the BD BACTEC FXI Culture System marks a significant step toward improving patient care and outcomes in the fight against sepsis and bloodstream infections.

About Waters Corporation:

Waters Corporation (NYSE: WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters aims to improve patient outcomes by detecting diseases earlier and managing routine infections effectively.

For more information on Waters Corporation and its innovative products, visit the company’s website.