Events

Retiro De Equipo (Recall) de VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)

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

¿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
    24657
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-05-26
  • 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
    A reference standardization of the roche vancomycin assays was done by the manufacturer against the reference method. it was decided to correct both methods against the reference method. the cobas integra assay was corrected by a reagent modification. the instruction for use of the vancomycin assays already show a method comparison against cobas integra with the changed formulation which is not yet available on the market. this may lead to the assumption that both methods are comparable and may affect the interpretation of results. since the cobas integra reagent is not yet adapted results generated with cobas integra are still up to 20% higher than with cobas c or modular p systems.

Device

VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)
  • Modelo / Serial
    Model Catalog: 04642481190 (Lot serial: all); Model Catalog: 04642490190 (Lot serial: all); Model Catalog: 04491050190 (Lot serial: all)
  • Descripción del producto
    VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITAC;VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI CO
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Dirección del fabricante
    LAVAL
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    HC