Products Affected :. Product VITROS® Immunodiagnostic Reagent Kit for β-hCG II Total --Register no. 80145901052 -> Code 6802220 -> Lots 1410, 1420, 1430, 1440, 1450, 1460, 1470 -> Class II. VITROS® Immunodiagnostic Calibrators for β-hCG II Total --Register nº80145901051 -> Code 6802221 -> Lots 1410, 1420, 1430, 1440, 1450, 1460, 147 -> Class II