Events

Retiro De Equipo (Recall) de ADVIA CHEMISTRY SYSTEM - TDM CALIBRATORS

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
    91455
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-05-08
  • 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
    Customer complaints indicate intermittent calibration failures due to max fit deviations when using digoxin reagents (smn 10327549) with therapeutic drug monitoring (tdm) calibrator lot 300645. in most cases customers were able to recalibrate the assay after repeat calibrations. if digoxin calibration does not pass on the advia chemistry system patient samples cannot be run or reported. there are only two current lots of tdm calibrators and both were evaluated for max fit deviations. this confirmed failure when using tdm calibrator lot 300645. the new tdm calibrator lot 324889 did not have any failed calibrations due to max fit deviations. the tdm calibrator is used only for the digoxin assay.

Device

ADVIA CHEMISTRY SYSTEM - TDM CALIBRATORS
  • Modelo / Serial
    Model Catalog: 01661874 (Lot serial: 300645)
  • Descripción del producto
    Advia Chemistry System-TDAM Calibrators
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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