Events

Retiro De Equipo (Recall) de ALLSET GOLD SSP HLA DIRECT TO HIGH RESOLUTION KITS

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
    16538
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-02-25
  • 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 each issue has been received. complaint states the dpb1 ssp unitray kit has a false negative in lane 30 which gives no perfect match typing result for the dpb1*29:01 allele. internal investigation has confirmed with the now available rare sample type that lane 30 is negative for the dpb1 *29 :01 allele in the listed affected kits according to the labeling provided with the kits. the primer mixes had not been tested with a dpb1 *29:01 sample the labeling stated the primers in lane 30 would amplify the targeted sequences in the dpb1 *29:01 allele.

Device

ALLSET GOLD SSP HLA DIRECT TO HIGH RESOLUTION KITS
  • Modelo / Serial
    Model Catalog: 54070D (Lot serial: 008 1127336); Model Catalog: 54070D (Lot serial: 008 1204422); Model Catalog: 451606D (Lot serial: > 10 contact manufacturer); Model Catalog: 451616D (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    AllSet Gold SSP HLA-DPB1 High Res Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION