Events

Retiro De Equipo (Recall) de SSP UNITRAY - HIGH RESOLUTION CLASS II

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

¿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
    44732
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-11-07
  • 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
    One complaint regarding this issue has been received. complaint states the drb1*04 ssp unitray kit has a false negative in lane 9 which gives no perfect match typing result for the drb1 *04:32 allele. internal investigation has confirmed with the now available rare sample type that lane 9 is false negative for the drb1 *04:32 allele in the listed affected kit according to the labeling provided with the kit. product does not meet specification. however the primer mix in lane 9 is functioning as originally intended. the drb1*04:32 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Modelo / Serial
    Model Catalog: 45040-4 (Lot serial: 010 666807); Model Catalog: 45040-4 (Lot serial: 010 727196); Model Catalog: 45040-4 (Lot serial: 011 989163)
  • Descripción del producto
    DRB1 *04 SSP UniTray Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION