FDA Clears Siemens’ New Mid-volume Coagulation Analyzer

Siemens Healthineers |  Jan 27, 2016

On January 27, Siemens received FDA clearance for the Sysmex® CS-2100i System, an automated mid-volume coagulation analyzer offering the same cutting-edge PSI technology as its high-volume counterpart, the Sysmex CS-5100 System. Combined with the recent FDA clearance of the CS-5100 System, this approval is further validation of Siemens Healthcare’s leadership in hemostasis testing solutions.


The systems’ high reliability, workflow efficiency, and first-to-market preanalytical checks of sample integrity have been enabling our customers to optimize and simplify operations while helping physicians support enhanced patient outcomes throughout the world. Since preanalytical errors and unsuitable samples account for up to 70% of mistakes in laboratory diagnostics,1 the Sysmex CS Systems technology improves sample management, automates and standardizes lab operations, and provides accurate first-run results.


The Sysmex CS-2100i System uses the same reagents, controls, and calibrators as other coagulation analyzers offered by Siemens. This enables true lab-to-lab consistency and offers labs confidence in multisite patient monitoring since results from the Sysmex CS-2100i System correlate with all other Sysmex CS and CA hemostasis systems.


For more information on hemostasis products, please visit http://usa.healthcare.siemens.com/hemostasis.


1. Lippi G, Banfi G, Buttarello M, et al. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med. 2007;45(6):728-736.


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