Events

Retiro De Equipo (Recall) de DIMENSION CLINICAL CHEMISTRY SYSTEM - RXL MAX ANALYZER - CLASS II

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    Recall
  • ID del evento
    19966
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-18
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has received complaints of qc and patient samplsiemens healthcare diagnostics has received complaints of qc and patient sample result accuracy shifts on ctni (rf421c) ltni (rf521c) ft4 (rf410) tsh (rfe result accuracy shifts on ctni (rf421c) ltni (rf521c) ft4 (rf410) tsh (rf412) pbnp (rf423a) and lpbn (rf523a) when using dimension chemistry wash lot rd41041on the dimension chemistry analyzers listed above. internal investigation has confirmed bacterial contamination in chemistry wash lot rd41041.

Device

DIMENSION CLINICAL CHEMISTRY SYSTEM - RXL MAX ANALYZER - CLASS II
  • Modelo / Serial
    Model Catalog: 752000.951 (Lot serial: ); Model Catalog: 766000.931 (Lot serial: ); Model Catalog: 752000.921 (Lot serial: ); Model Catalog: 750300.501 (Lot serial: ); Model Catalog: 756000902 (Lot serial: ); Model Catalog: 778021.911 (Lot serial: ); Model Catalog: 756010901 (Lot serial: ); Model Catalog: 756000901 (Lot serial: ); Model Catalog: 756010.912 (Lot serial: ); Model Catalog: 766000.511 (Lot serial: ); Model Catalog: 752000.931-R (Lot serial: ); Model Catalog: 752000.931 (Lot serial: ); Model Catalog: 765000.931 (Lot serial: ); Model Catalog: 778041.931 (Lot serial: ); Model Catalog: 778000.941 (Lot serial: ); Model Catalog: 10459239 (Lot serial: ); Model Catalog: 756010.501 (Lot serial: FOR ALL DEVICES); Model Catalog: 756000901 (Lot serial: FOR ALL DEVICES); Model Catalog: 756010.912 (Lot serial: FOR ALL DEVICES); Model Catalog: 756010.501 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 756000901 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 756010.912 (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    DIMENSION CLINICAL CHEMISTRY SYSTEM-RXL MAX ANALYZER (LICENCE 2232)
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC