Events

Retiro De Equipo (Recall) de ALLSET GOLD ABC LOW RESOLUTION KIT

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
    94329
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-08
  • 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 has been received. drb1 high res ssp unitray kits have a false negative in lane 44 for drb1*04:33 allele. internal investigation confirmed by sequence based typing that the customer had a drb1*04:33 allele. therefore lane 44 has a confirmed false negative in the affected kits according to the labeling. however the primer mix in lane 44 is functioning as originally designed. the drb1*04:33 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing.

Device

ALLSET GOLD ABC LOW RESOLUTION KIT
  • Modelo / Serial
    Model Catalog: 54340D (Lot serial: 017 904113); Model Catalog: 54340D (Lot serial: 017 1001675); Model Catalog: 54340D (Lot serial: 017 845070); Model Catalog: 45150-10 (Lot serial: 017 944896); Model Catalog: 45150-10 (Lot serial: 017 1103807)
  • Descripción del producto
    AllSet Gold SSP HLA-DRB1 High Res Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION