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
    31759
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-06-06
  • 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
    Internal investigation identified a trend of three complaints regarding lanes 27 and 39 giving false negative results for a dpb1*126:01 allele. the primer mixes within lanes 27 and 39 target regions of the dpb1*126:01 allele which are undefined. currently there are qc comments provided with the kit about the primers in the affected lanes stating that they have predicted reactivity. the dpb1*126:01 allele reactivity is assigned according to the common alleles. the primer mixes have not been tested with a dpb1*126:01 sample the labeling stated the primers in lanes 27 and 39 would amplify the targeted sequences in the dpb1*126:01 allele.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Modelo / Serial
    Model Catalog: 451606D (Lot serial: > 10 contact manufacturer); Model Catalog: 451616D (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    DPB1 SSP UniTray Kit/DPB1 SSP UniTray Kit with Taq Polymerase
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION