Waters Corporation’s BD Bactec FXI Culture System has received CE marking under the European Union’s In Vitro Diagnostic Regulation (IVDR), enabling commercialisation in Europe and marking a milestone in the Company’s expansion of its clinical microbiology portfolio.
The BD Bactec FXI system is a next-generation, fully automated blood culture system that can improve the speed, consistency, and accuracy of bloodstream infection diagnostics in modern microbiology labs.
Clinical study data found that the BD Bactec FXI system can deliver a mean time to detection three hours faster than the previous-generation BD Bactec FX System, helping detect pathogens earlier and enabling more timely initiation of targeted antimicrobial therapy in patients with suspected bloodstream infections and sepsis.
Rafael Cantón, head of Clinical Microbiology, University Hospital Ramón y Cajal – IRYCIS, Madrid, said, “In the context of sepsis, diagnostics are critical to supporting informed clinical decision-making and ultimately improving antimicrobial stewardship and patient care. Based on our experience during clinical trials, the BD Bactec FXI System reflects a mature and robust approach to blood culture diagnostics, with a clear focus on system reliability, ease of use, and laboratory workflow.”
The BD Bactec FXI System features automated gravimetric measurement of individual blood culture vial volume, the first-of-its-kind capability in a blood culture platform. Studies indicate that up to 85% of blood culture vials are filled inappropriately in routine clinical practice, negatively impacting diagnostic accuracy. By objectively confirming blood volume in each vial, the system addresses a known source of pre-analytical variability and supports greater diagnostic consistency and adherence to recommended collection practices.
The BD Bactec FXI System has been developed for modern, high-throughput microbiology labs and features fully automated workflows including vial loading, unloading, incubation, and detection alerts. It offers an automated loading capacity of up to 60 vials at a time, reducing manual intervention and increasing walkaway time. The BD Bactec FXI System also provides flexibility and right-sized solutions for labs of varying sizes, with modules accommodating 480 and 960 vials, allowing laboratories to efficiently manage high testing volumes while staff can focus on more clinically important tasks.
Jianqing Bennett, senior vice president, Waters Advanced Diagnostics, Waters Corporation, said, “The BD Bactec FXI Culture System represents a significant advancement in automated microbiology, combining speed, automation, and scalability to support laboratory modernisation. This system strengthens our position in clinical microbiology and expands our ability to address the growing global demand for faster, more reliable infectious disease testing.”
To prepare for launch and increased adoption, Water Corporation has strengthened its manufacturing supply chain by diversifying sourcing, reinforcing supplier partnerships, and improving operational resilience, while retaining a strong commitment to quality to ensure consistent, reliable delivery.
