Events

Retiro De Equipo (Recall) de DIMENSION CHEMISTRY WASH

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
    63778
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-05-17
  • 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 chemistry wash causing qc and patient sample result shifts on ctni ltni ft4 tsh pbnp and lpbn when using chemistry wash lots rd23031 rd23111 rd23241 rd23311 rd23391 and rd23461. these lots shipped between 12/12/2012 and 3/22/2013. internal investigation has confirmed shifts can be encountered in two scenarios: 1. when an affected lot of chemistry wash is placed on the instrument following an unaffected lot a negative bias will be seen on ctni ltni tsh pbnp and lpbn. a positive bias will be seen on ft4. 2. if any of these assays are calibrated using an affected lot of chemistry wash qc should return within range but when a subsequent unaffected chemistry wash lot is placed into use a positive bias will be seen on ctni ltni tsh pbnp and lpbn. a negative bias will be seen on ft4.

Device

DIMENSION CHEMISTRY WASH
  • Modelo / Serial
    Model Catalog: 10445052 (Lot serial: RD23031); Model Catalog: 10445052 (Lot serial: RD23111); Model Catalog: RD701 (Lot serial: RD23241); Model Catalog: 10445052 (Lot serial: RD23241); Model Catalog: RD701 (Lot serial: RD23311); Model Catalog: RD701 (Lot serial: RD23031); Model Catalog: RD701 (Lot serial: RD23391); Model Catalog: 10445052 (Lot serial: RD23391); Model Catalog: RD701 (Lot serial: RD23461); Model Catalog: 10445052 (Lot serial: RD23461); Model Catalog: RD701 (Lot serial: RD23111); Model Catalog: 10445052 (Lot serial: RD23311)
  • Descripción del producto
    DIMENSION CHEMISTRY WASH
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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