Events

Retiro De Equipo (Recall) de CLINITEK STATUS SYSTEM - URINE CHEMISTRY ANALYZER

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
    149525
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-02-01
  • 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
    An internal product review determined that there was an issue with software versions 2.60/2.4.0.0 and 2.61/2.4.1.0 for the clinitek status+ connect systems which could potentially affect patient results. in the case that an operator transmits all of the data stored in the instrument to an lis or data manager by selecting the "send all" function the software will allow the operator to perform a urinalysis strip or cassette test while data is still being transferred. in this case the instrument may be slow to respond. depending on the amount of data being transferred and the speed at which it is transferred there may be a delay in timing when the urinalysis reagents are read by the analyzer. this delay in read time may potentially affect patient results.

Device

CLINITEK STATUS SYSTEM - URINE CHEMISTRY ANALYZER
  • Modelo / Serial
    Model Catalog: CLINITEK STATUS+ (Lot serial: SW versions 2.61); Model Catalog: CLINITEK STATUS+ (Lot serial: SW versions 2.60)
  • Descripción del producto
    CLINITEK Status+
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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