CHEMICAL SYSTEM VITROS 4600 (Reg 80145900827) / CHEMICAL SYSTEM VITROS 5,1 FUSION (Reg 80145900827). Hazard Class: I. Products Affected: All VITROS® 4600 Diagnostic Systems with softaware version 3.2 and earlier and all VITROS® 5.1 Fusion Diagnostic Systems with software version 2.8 and earlier. List of affected SNs distributed in Brazil are in Annex I of this notification.