Events

Retiro De Equipo (Recall) de ID-MICRO TYPING SYSTEM - INSTRUMENTATION

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL 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
    77742
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-02-15
  • 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
    As an expansion to recall id 79537 ocd has recalled 3 lots of mts anti-igg card (mts084024) based on customer complaints of incomplete foil seals on the gel cards. although internal investigation demonstrated acceptable peel strength for the 3 affected lots and no complaints of erroneous results have been reported due to this issue ocd would like to remind users to inspect their gel cards upon receipt (as instructed by the product labeling).

Device

ID-MICRO TYPING SYSTEM - INSTRUMENTATION
  • Modelo / Serial
    Model Catalog: MTS084024 (Lot serial: 090612001-11); Model Catalog: MTS084024 (Lot serial: 090612001-15); Model Catalog: MTS084024 (Lot serial: 090612001-05)
  • Descripción del producto
    MTS Anti-IgG Card
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS