Events

Retiro De Equipo (Recall) de THYROID TRANSCRIPTION FACTOR-1 ANTIBODY LYOPHILISED MOUSE MONOCLONAL

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

¿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
    18824
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-08-10
  • 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
    Leica received a complaint from a customer regarding bond rtu ttf-1 (product code pa0364) giving positive staining on thymoma tissue which was thought to be negative. the ttf-1 antigen had previously been characterised as staining thyroid and lung tumours only and this is the claim made on the instruction for use (ifu). our investigations following this complaint have demonstrated that ttf-1 has a wider expression than was originally thought.

Device

THYROID TRANSCRIPTION FACTOR-1 ANTIBODY LYOPHILISED MOUSE MONOCLONAL
  • Modelo / Serial
    Model Catalog: NCL-TTF-1 (Lot serial: 136439); Model Catalog: NCL-TTF-1 (Lot serial: 136442); Model Catalog: NCL-TTF-1 (Lot serial: 136441S); Model Catalog: NCL-TTF-1 (Lot serial: 136447); Model Catalog: NCL-TTF-1 (Lot serial: 6000563); Model Catalog: NCL-TTF-1 (Lot serial: 6004009); Model Catalog: NCL-L-TTF-1 (Lot serial: L136443); Model Catalog: NCL-L-TTF-1 (Lot serial: L136446); Model Catalog: NCL-L-TTF-1 (Lot serial: 6000568); Model Catalog: NCL-L-TTF-1 (Lot serial: 6002638); Model Catalog: NCL-L-TTF-1 (Lot serial: L136434); Model Catalog: NCL-L-TTF-1 (Lot serial: L136437); Model Catalog: PA0364 (Lot serial: 05918); Model Catalog: PA0364 (Lot serial: 06912); Model Catalog: PA0364 (Lot serial: 07104); Model Catalog: PA0364 (Lot serial: 08679); Model Catalog: PA0364 (Lot serial: 10903); Model Catalog: PA0364 (Lot serial: 10480)
  • Descripción del producto
    TTF-1 PRIMARY ANTIBODIES
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA