Retiro De Equipo (Recall) de Roche Benchmark Ultra clinical chemistry analysers

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    Internal investigations by roche diagnostics have uncovered the potential for incorrect slide staining (ihc/ish) to occur on the benchmark ultra instrument or discovery ultra instrument running ventana system software (vss) 11.9 or higher, due to the possibility of a duplicate keycode error., the embedded software for the barcode reader has an identified issue, which on presentation of this error may result in two slides erroneously receiving the same stain protocol regardless of what should have been indicated in the software for that keycode. the barcode reader fails to purge previously read barcode information and applies the same protocol details to a subsequent slide.
  • Acción
    Software to be upgraded


  • Modelo / Serial
    Model: 5342716001, Affected: Software Versions VSS 11.9 or higher
  • Manufacturer