Waters Announces CE Mark for Next-Generation Fully Automated BD BACTEC FXI Culture System for Bloodstream Infection Diagnosis
- Achieves a ~3‑hour faster time to detection (~15% reduction) versus the prior generation system, per clinical study data,¹ enabling earlier targeted therapy.
- First‑of‑its‑kind blood volume measurement objectively confirms sample collection quality in every bottle processed, improving confidence in blood culture results.2,3
- Industry-leading automation with flexible 60-sample loading and up to 960 vials per module capacity, maximizing walk-away time and minimizing manual intervention.4
MILFORD, Mass., April 15, 2026 /PRNewswire/ -- Waters Corporation (NYSE: WAT) today announced that the BD BACTEC™ FXI Culture System has received CE marking under the European Union's In Vitro Diagnostic Regulation (IVDR), enabling commercialization in Europe and representing a key milestone in the Company's clinical microbiology portfolio expansion. 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.
Clinical study data1 show that the BD BACTEC FXI System delivers a mean time to detection approximately three hours faster (~15% reduction) than the previous generation BD BACTEC™ FX System, supporting earlier detection of pathogens and more timely initiation of targeted antimicrobial therapy in patients with suspected bloodstream infections and sepsis. In 2021, sepsis-related deaths represented 31.5% of total global deaths,5 with studies showing that each hour of delay in antibiotic administration is associated with increased odds of mortality.6
"In the context of sepsis, diagnostics are critical to supporting informed clinical decision-making and ultimately improving antimicrobial stewardship and patient care," said Rafael Cantón, Ph.D., Head of Clinical Microbiology, University Hospital Ramón y Cajal – IRYCIS, Madrid. "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 innovation of the BD BACTEC FXI System is its automated gravimetric measurement of individual blood culture vial volume, the first-of-its-kind capability in a blood culture platform. Studies indicate up to 85% of blood culture vials are inappropriately filled in routine clinical practice,2 negatively impacting diagnostic accuracy.3 By objectively confirming blood volume in each vial, the system addresses a well-established source of pre-analytical variability and supports improved diagnostic consistency and adherence to recommended collection practices.
The BD BACTEC FXI System is designed for modern, high-throughput microbiology laboratories, featuring fully automated workflows including vial loading, unloading, incubation, and detection alerts. It offers an industry-leading automated loading capacity of up to 60 vials at a time,4 reducing manual intervention and significantly increasing walkaway time. In addition, the BD BACTEC FXI System offers flexibility and right-sized solutions for labs of varying sizes, with modules accommodating 480 and 960 vials,4 enabling laboratories to efficiently manage high testing volumes while allowing staff to focus on more clinically important tasks.
"The BD BACTEC FXI Culture System represents a significant advancement in automated microbiology, combining speed, automation, and scalability to support laboratory modernization," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation. "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."
In preparation for launch and increased adoption, the Company has reinforced its manufacturing supply chain by diversifying sourcing, strengthening supplier partnerships, and improving operational resilience, while maintaining a strong commitment to quality to ensure consistent, reliable delivery.
Waters Corporation will showcase the BD BACTEC FXI System at ESCMID Global 2026 in Munich, including live demonstrations at Booth C60.
The BD BACTEC FXI Culture System is currently available in Europe and Japan.7 The Company is pursuing additional regulatory clearances and approvals in other key global markets.
Additional Resources:
- The BD BACTEC FXI System and BD BACTEC™ Blood Culture Vials are manufactured by Becton, Dickinson and Company or one of its affiliates or subsidiaries.
BD is a trademark of Becton, Dickinson and Company. Waters is a trademark of Waters Corporation or its affiliates. All other marks are the property of their respective owners.
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, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide. For more information, please visit www.waters.com/aboutus.
Disclaimer:
The BD Biosciences and BD Diagnostic Solutions businesses have been acquired by Waters Corporation ("Waters"). Becton, Dickinson and Company or one of its affiliates or subsidiaries ("BD") remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed. During this interim period, BD maintains full responsibility for all regulatory obligations of the legal manufacturer. Product information provided here is supplied under BD's regulatory authority. To learn more about the relationship between Waters and BD during this transition period, please see our detailed summary: www.waters.com/bdtransaction.
References:
- Data on file BD, Clinical Performance Study Report IDS-23BACT002. Overall faster time to detection (TTD) 2.8-hrs – 3.2-hrs. (Mean TTD) BD BACTEC™ Plus Aerobic media 2.8-hrs faster, BD BACTEC™ Lytic Anaerobic media 3.2-hrs faster.
- Fabre V, Carroll KC, Cosgrove SE. Blood Culture Utilization in the Hospital Setting: a Call for Diagnostic Stewardship. J Clin Microbiol. 2022 Mar 16;60(3):e0100521. doi: 10.1128/JCM.01005-21. Epub 2021 Jul 14. PMID: 34260274; PMCID: PMC8925908.
- Khare R, Kothari T, Castagnaro J, Hemmings B, Tso M, Juretschko S. Active Monitoring and Feedback to Improve Blood Culture Fill Volumes and Positivity Across a Large Integrated Health System. Clin Infect Dis. 2020 Jan 2;70(2):262-268. doi: 10.1093/cid/ciz198.
- Specification Data on File, Becton, Dickinson and Company 2026
- Gray A, Chung E, Hsu R et al. Global, regional, and national sepsis incidence and mortality, 1990–2021: a systematic analysis The Lancet Global Health, 2025; 13, e2013-e2026
- Jiao Huang, Jiang-tao Yang, Jing-chen Liu, The association between mortality and door-to-antibiotic time: a systematic review and meta-analysis, Postgraduate Medical Journal, Volume 99, Issue 1175, September 2023, Pages 1000–1007, https://doi.org/10.1093/postmj/qgad024
- Japan Pharmaceuticals and Medical Devices Agency (PMDA), License No. 13B1X10407
Contact:
Molly Gluck
Head of External Communications
Waters Corporation
508.498.9732
molly_gluck@waters.com
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