Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 10488064, 10488062, 10709128Affected Applications: Protein C with Protein C Reagent (OQYG11), Protein S with Protein S Ac Reagent (OPAP03) and Factor V Leiden with ProC Global Reagent (OQLS13)ARTG number:179939