The next-generation system is designed to accelerate pathogen detection and improve diagnostic accuracy for bloodstream infections.
Waters Corp announced that the BD BACTEC FXI Culture System has received CE marking under the European Union In Vitro Diagnostic Regulation. The system is a next-generation, fully automated blood culture platform designed to improve the speed, consistency, and accuracy of bloodstream infection diagnostics in microbiology laboratories.
Clinical study data show the system delivers a mean time to detection approximately three hours faster than the previous-generation system, representing a 15% reduction in time. This supports earlier detection of pathogens and faster initiation of antimicrobial therapy for patients with suspected sepsis. Sepsis-related deaths accounted for 31.5% of total global deaths in 2021, and research indicates that each hour of delay in antibiotic administration increases mortality risks.
“In the context of sepsis, diagnostics are critical to supporting informed clinical decision-making and ultimately improving antimicrobial stewardship and patient care,” says Rafael Cantón, PhD, head of clinical microbiology at University Hospital Ramón y Cajal – IRYCIS, Madrid, in a release. “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.”
A key feature of the system is the automated gravimetric measurement of individual blood culture vial volumes. This capability addresses pre-analytical variability, as studies suggest up to 85% of blood culture vials are inappropriately filled in clinical practice, which can negatively impact diagnostic accuracy. By objectively confirming blood volume in each vial, the system supports improved diagnostic consistency and adherence to collection practices.
Designed for high-throughput laboratories, the platform includes fully automated workflows for 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 for laboratory staff. The system also offers modules accommodating 480 and 960 vials to help laboratories of varying sizes manage high testing volumes.
“The BD BACTEC FXI Culture System represents a significant advancement in automated microbiology, combining speed, automation, and scalability to support laboratory modernization,” says Jianqing Bennett, senior vice president of Waters Advanced Diagnostics at Waters Corp, in a release. “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.”
The system is currently available in Europe and Japan. The company is pursuing additional regulatory clearances and approvals in other global markets. Waters Corp demonstrated the platform at ESCMID Global 2026 in Munich.
Photo caption: The BD BACTEC FXI System is a next-generation, fully automated blood culture system designed to improve the speed, consistency, and accuracy of bloodstream infection diagnostics in modern microbiology laboratories, currently available in Europe and Japan.
Photo credit: Waters Corp
