Retiro De Equipo O Alerta De Seguridad para Chromogenic Factor VIII Assay, catalog number B4238-40, lot number 44637, used in the Sysmex® CA- / CS Systems

The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.