Events

Retiro De Equipo (Recall) de SSP UNITRAY - HIGH RESOLUTION CLASS I

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
    17645
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-29
  • 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
    Internal investigation has confirmed that primer mix b-086 found on lane 83 in the b high resolution allset gold and ssp unitray kits and on lane 9 of the b17 ssp unitray and allset gold kits gives a false negative for the b*47:03 allele according to the labeling. however the primer mix b-086 is functioning as originally designed. the b*47:03 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing due to lack of sample availability.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Modelo / Serial
    Model Catalog: 47230-3 (Lot serial: 009 984375); Model Catalog: 47300-10 (Lot serial: 009 984375); Model Catalog: 47230-3 (Lot serial: 010 1103786); Model Catalog: 47300-10 (Lot serial: 010 1103786); Model Catalog: 47230-3 (Lot serial: 004 743203); Model Catalog: 47300-10 (Lot serial: 004 743203); Model Catalog: 47230-3 (Lot serial: 008 709385); Model Catalog: 47300-10 (Lot serial: 008 709385); Model Catalog: 47230-3 (Lot serial: 008 757730); Model Catalog: 47300-10 (Lot serial: 008 757730); Model Catalog: 47230-3 (Lot serial: 008 800850); Model Catalog: 47300-10 (Lot serial: 008 800850); Model Catalog: 47230-3 (Lot serial: 008 839301); Model Catalog: 47300-10 (Lot serial: 008 839301); Model Catalog: 47230-3 (Lot serial: 008 873000); Model Catalog: 47300-10 (Lot serial: 008 873000); Model Catalog: 54020D (Lot serial: 009 979631); Model Catalog: 47230-3 (Lot serial: 009 910766); Model Catalog: 47300-10 (Lot serial: 009 910766)
  • Descripción del producto
    B17 SSP UniTray Kit/B Locus High Res SSP UniTray Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION