Events

Retiro De Equipo (Recall) de MICRO SSP HIGH RESOLUTION HLA CLASS II DNA TYPING TRAYS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ONE LAMBDA INC.

¿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
    26575
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-03-01
  • 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
    Null allele information on the lot specific documents of these products is incorrect and may cause mis-assignment- refer to table 1- reaction patterns and potential mis-assignments. the root cause investigations determined that null allele entries during nomenclature update were not verified per standard operating procedure. no adverse events or product complaints have been received.

Device

MICRO SSP HIGH RESOLUTION HLA CLASS II DNA TYPING TRAYS
  • Modelo / Serial
    Model Catalog: SSP2LB (Lot serial: SSP2H LOT 005EXP 1/2015); Model Catalog: SSP1-26 (Lot serial: SSP2H LOT 005EXP 1/2015); Model Catalog: SSPR1-11 (Lot serial: SSP2H LOT 005EXP 1/2015); Model Catalog: SSP1-11 (Lot serial: SSP2H LOT 005EXP 1/2015); Model Catalog: SSP2L (Lot serial: SSP2H LOT 005EXP 1/2015); Model Catalog: SSP2H (Lot serial: SSP2H LOT 005EXP 1/2015); Model Catalog: SSPML02 (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSPDRQP1 (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSPABDRX (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSPABDR (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSP2LB (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSP1-26 (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSPR1-11 (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSP1-11 (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSP2L (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSP2H (Lot serial: SSP1-26LOT 01AEXP 5/2013); Model Catalog: SSPML02 (Lot
  • Descripción del producto
    MICRO SSP DNA TYPING TRAYS
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC