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
    80620
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-11-29
  • 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 dpb1 ssp unitray kit has a false negative in lanes 27 30 and 39 which gives no perfect match typing result for the dpb1*53:01 allele. internal investigation has confirmed with the now available rare sample type that lanes 27 30 and 39 are negative for the dpb1*53:01 allele in the above listed affected kits according to the labeling provided with the kits. however the primer mixes in lanes 27 30 and 39 are functioning as originally intended. the primer mixes within lanes 27 30 and 39 target regions of the dpb1*53:01 allele which are undefined.

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); Model Catalog: 54070D (Lot serial: 008 1127336)
  • Descripción del producto
    DPB1 SSP UniTray Kits (with our without Taq Polymerase)
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION