Retiro De Equipo (Recall) de COULTER GEN*S SLIDESTAINER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    Beckman coulter has identified the following four (4) issues with the products: issue 1:there is a potential for misidentification to occur when the system is configured in languages other than english or chinese. the characters #@[]`{|}~ are substituted or omitted in other languages. the issue affects the gens lh750 lh780 lh500 and dxh 800. issue 2:independent of language the dxh 800 omits the characters *?" when used as part of the selected demographics including specimen id and patient id. issue 3:in the dxh 800 space(s) used as leading character(s) in a patient or specimen id can cause random insertion of extra character(s) within that identifier. issue 4:the lh500 instrument omits the tilde character (~) from the barcode when read by the primary mode (automatic aspiration) scanner.


  • Modelo / Serial
    Model Catalog: 6605470 (Lot serial: ALL); Model Catalog: 6605681 (Lot serial: ALL); Model Catalog: 178833 (Lot serial: ALL); Model Catalog: 6605360 (Lot serial: ALL); Model Catalog: 629029 (Lot serial: ALL); Model Catalog: 723585 (Lot serial: ALL); Model Catalog: 6605632 (Lot serial: ALL)
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source