Events

Retiro De Equipo (Recall) de MICROSCAN 10% FERRIC CHLORIDE

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
    25575
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-07-19
  • 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
    A siemens healthcare diagnostics investigation has confirmed b1015-48 microscan 10% ferric chloride smn 10444551 lot 2014-03-26 a portion of the 10% ferric chloride reagent bottle labels were printed with an incorrect lot/expiration of 2015-03-26 instead of 2014-03-26. the incorrect lot number was found randomly through-out the lot. the effect is the potential for using this lot of 10% ferric chloride reagent past the correct expiration dating of 2014-03-26. there is no health risk with the product since this 10% ferric chloride reagent lot is still within the expiration dating of 2014-03-26. therefore it is not necessary for the customer to review previous test results or to repeat testing.

Device

MICROSCAN 10% FERRIC CHLORIDE
  • Modelo / Serial
    Model Catalog: B1015-48 (Lot serial: 2014-03-26)
  • Descripción del producto
    MICROSCAN 10% FERRIC CHLORIDE
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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