• FDA 510(k)-cleared BD BACTEC™ FXI Culture System now available to U.S. market, enabling broader access to confident bloodstream infection diagnostics.
• Achieves a 3-hour faster time to detection (~15% reduction) versus the prior-generation system, per clinical study data, enabling earlier targeted sepsis prevention.
• Fully automated solution delivers an industry-leading 50% increase in vial loading and up to 960-vial per module capacity, maximizing walk-away time.

MILFORD, Mass., June 3, 2026 /PRNewswire/ -- Waters Corporation (NYSE: WAT) today announced that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance. This clearance enables commercialization in the U.S. and provides a new option for laboratories seeking a fully automated blood culture system designed to improve the speed, consistency, and accuracy of sepsis and bloodstream infection diagnostics in modern microbiology laboratories.

Clinical study data¹ showed that the BD BACTEC FXI Culture System reduced mean time to detection by approximately three hours (~15%) compared with the previous-generation BD BACTEC™ FX Blood Culture System (17 hours vs. 20 hours). Faster detection enables earlier pathogen identification and more timely targeted antimicrobial therapy for patients with suspected bloodstream infections and sepsis. Because each hour of delayed sepsis treatment increases mortality by 3.6% to 9.9%,² faster diagnostic workflows are critical in acute care settings.

"Recent evidence-based laboratory guidelines document the beneficial clinical impact of rapid laboratory results for the detection of bloodstream infections; therefore, advancing the science of automated blood culture instruments is critical to further speed results," said Donna M. Wolk, MHA, Ph.D., D(ABMM), Division Chief, Molecular and Microbial Diagnostics and Development, Geisinger Medical Laboratories. "Reducing the time to detection for positive results is key to improving the availability of Gram stain and other tests, on which treatment decisions are based. The faster, the better."

The BD BACTEC FXI Culture System features a first-of-its-kind capability in a blood culture platform – an automated gravimetric measurement of individual blood culture vial volume. By objectively confirming blood volume in each vial, the system reduces pre-analytical variability and supports more consistent diagnostics and adherence to recommended collection practices.

"Waters is proud to bring the BD BACTEC FXI Culture System to the U.S. market, delivering an important advancement in bloodstream infection diagnostics," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation. "This innovation reflects the scientific expertise and commitment of the Waters team to improve patient care. The system helps laboratories support earlier clinical decisions for patients with suspected sepsis and bloodstream infections when every hour matters."

Designed for high-throughput microbiology labs, the BD BACTEC FXI Culture System fully automates vial loading, unloading, incubation, and detection alerts, with an industry-leading automated loading capacity of up to 60 vials at a time,³ 50% more vials than the leading competitior.⁴ Available in 480- and 960-vial configurations,³ the BD BACTEC FXI Culture System delivers scalable efficiency while reducing manual intervention and increasing staff walk-away time.

The BD BACTEC FXI Culture System was recently CE marked under the European Union's In Vitro Diagnostic Regulation (IVDR) and licensed by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for availability in Europe⁵ and Japan.⁶

Additional Resources:

The BD BACTEC FXI Culture 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:

1. Data on file BD, Clinical Performance Study Report IDS-23BACT002. Overall faster mean time to detection 2.8-hrs – 3.2-hrs compared to BD BACTEC FX Blood Culture System for BD BACTEC™ Plus Aerobic media and BD BACTEC™ Lytic Anaerobic media, respectively.
2. Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589-96. PMID 16625125.
3. Specification Data on File, Becton, Dickinson and Company 2026.
4. Specification data from BACT/ALERT® VIRTUO® 510(k) Substantial Equivalence Determination Decision Summary (K161816); page 5, Table J3.
5. Waters Press Release, April 15, 2026: https://www.prnewswire.com/news-releases/waters-announces-ce-mark-for-next-generation-fully-automated-bd-bactec-fxi-culture-system-for-bloodstream-infection-diagnosis-302743121.html.
6. 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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Österreich hat drei russische Diplomaten wegen des Verdachts der Spionage des Landes verwiesen und sie zu „persona non grata“ erklärt. Nach Angaben der Regierung sollen die betroffenen Mitarbeiter der russischen Vertretungen in Wien in Aktivitäten verwickelt gewesen sein, die als nachrichtendienstliche Operationen gelten. Die Außenministerin Beate Meinl-Reisinger betonte, es sei „inakzeptabel“, diplomatische Immunität für Spionage zu nutzen. Laut einer Erklärung aus Wien haben die drei Diplomaten Österreich bereits verlassen.

Nach Berichten des österreichischen Rundfunks ORF sollen die Diplomaten direkt in satellitengestützte Überwachungstätigkeiten involviert gewesen sein. Es geht demnach um mutmaßliche Spionage gegen in Wien ansässige internationale Organisationen unter Nutzung von Satellitentechnik auf dem Gelände der russischen Botschaft und des russischen Diplomatenkomplexes. Die Regierung hatte bereits im April die Aufhebung der diplomatischen Immunität der drei Betroffenen gefordert, Moskau kam dieser Forderung jedoch nicht nach. Die österreichische Außenministerin verwies in diesem Zusammenhang auf die „Vielzahl von Antennen“ auf den Dächern russischer Vertretungen in Wien, die als Sicherheitsrisiko eingestuft werden.

Wien reagiert auf den Fall auch mit einer geplanten Verschärfung des Strafrechts. Bislang ist Spionage durch ausländische Nachrichtendienste in Österreich nur strafbar, wenn sie sich direkt gegen österreichische Interessen richtet. Die Bundesregierung will nach einem Vorschlag des Justizministeriums einen zusätzlichen Tatbestand einführen, der auch die Interessen internationaler Organisationen – etwa der Vereinten Nationen und ihrer Spezialorganisationen mit Sitz in Wien – schützt. Zudem sollen bestehende Spionageparagrafen verschärft werden. Wien ist nach New York und Genf eines der wichtigsten diplomatischen Zentren weltweit und beherbergt zahlreiche internationale Einrichtungen.

Das russische Botschaftspersonal reagierte empört auf die Entscheidung. Die russische Botschaft in Wien bezeichnete die Ausweisung als „ungehörig, unbegründet, politisch motiviert und völlig inakzeptabel“ und kündigte „scharfe Gegenmaßnahmen“ an. Nach Angaben von Medien sind in Österreich rund 220 Mitarbeiter der russischen Botschaft akkreditiert; seit Beginn des russischen Militäreinsatzes in der Ukraine im Jahr 2022 wurden bereits rund ein Dutzend russischer Diplomaten des Landes verwiesen. Nach Zählung der Nachrichtenagentur Reuters summierten sich die Ausweisungen seit 2020 auf 14 russische Diplomaten. Aus Moskau kam zunächst keine detaillierte Reaktion auf die jüngste Entscheidung der österreichischen Regierung.