Events

Retiro De Equipo (Recall) de ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY

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
    43802
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-03-26
  • 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 confirmed one set of complaints with the advia centaur systems folate kit lots ending in 223. customers observed that the bio-rad liquichek and lyphochek folate serum controls may go out of range low with advia centaur systems folate kit lots ending in 223. whole blood controls with advia centaur folate reagent kit lots ending in 223 are within range and whole blood patients are consistent with previous reagent lots. in addition siemens has confirmed a second set of customer complaints regarding a shift in whole blood patients when moving from advia centaur systems folate kit lots ending in 219 to kit lots ending in 222224 225 226 and/or 227. siemens performed a whole blood normal range study that shows kit lots ending in 219 do not demonstrate a normal range pattern shown in the instructions for use (ifu). serum controls and patients show normal lot to lot variation with all in date lots of folate reagents.

Device

ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY
  • Modelo / Serial
    Model Catalog: 131096 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 06891541 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 124838 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 06367974 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 118551 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 126638 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 131096 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 06891541 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 124838 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 06367974 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 118551 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 126638 (Lot serial: 226227 FOR ALL DEVICES)
  • Descripción del producto
    ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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