Product name: VITROS 4600 CHEMICAL SYSTEM / VITROS 5600 INTEGRATED SYSTEM Technical Name: Biochemical Analyzer / Biochemical Analyzer ANVISA Registration Number: 80145901335 Hazard Class: I Affected Model: Vitros 4600 Chemical (Viton 4600 / 5600 (R.Anvisa 80145901205) Serial numbers affected: VITROS® 4600 Chemistry System, Software Version 3.3, Product Code 6802445. VITROS® 5600 Integrated System, Software Version 3.3, Product Code 6802413 and 6802915.