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
    98310
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-02-27
  • 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
    There are three reactivity updates with respect to these kits: 1. in primer mix dpb004 (lane 4) the reactivity for the dpb1*31:01 has been updated from positive to negative. prior to this update in the presence of the dpb1*31:01 allele users may have obtained a negative reaction leading to a no-type result. 2. in primer mix dpb027b (lane 27) and dpb039a (lane 39) the reactivity for the dpb1*88:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*88:01 allele users may have obtained a negative reaction leading to a no-type result. 3. in primer mix dpb039a (lane 39) the reactivity for the dpb1*29:01 allele has been updated from positive to negative. prior to this update in the presence of the dpb1*29:01 allele users may have obtained a negative reaction leading to a no-type result.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Modelo / Serial
    Model Catalog: 451606D (Lot serial: > 10 numbers contact mfg); Model Catalog: 451616D (Lot serial: > 10 numbers contact mfg); Model Catalog: 54070D (Lot serial: 008 1127336); Model Catalog: 54070D (Lot serial: 008 1204422); Model Catalog: 54070D (Lot serial: 008 1256851); Model Catalog: 54070D (Lot serial: 009 1377591); Model Catalog: 54070D (Lot serial: 008 1073448)
  • Descripción del producto
    DPB1 SSP UNITRAY 12 TESTS DPB1 SSP UNITRAY W/TAQ 12 TEST
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION