Products Affected: VITROS ANALYZING SYSTEM / CHEMICAL SYSTEM VITROS 4600 / CHEMICAL SYSTEM VITROS 5600 / CHEMICAL SYSTEM VITROS 5.1 FUSION. Anvisa Registers: 10132590681. VITROS® 250 System (Reg ANVISA 10132590681). VITROS® 350 System (Reg ANVISA 10132590681). VITROS® 4600 Chemical System (Reg ANVISA 80145901335). VITROS® 5600 Integrated System (Reg ANVISA 80145901205). VITROS® 5.1 Fusion Chemical System (Reg ANVISA 80145900827). Risk class: II. Affected Series / Lots: Includes all VITROS® 250, 350, 4600, 5600 and 5.1FS Diagnostic Systems.