Name of products: Immunodiagnostic reagent Vitros for Syphilis TPA, ANVISA Registry 80145901397. Classification IV. 7,400 affected units were imported by Brazil, of which 4,300 were distributed in the Brazilian market. Only one product code was affected (6842803), and the lots and distribution site 0514 (300 units in Belo Horizonte MG, 100 units in Tangará da Serra-MT, 2,900 units in Curitiba-PR, 100 units Campos dos Goytacazes-RJ and 100 units in São Gonçalo-RJ), 0515, 0520 (700 units in Campos dos Goytacazes-RJ and 100 units in Piracicaba), 0531