Retiro De Equipo (Recall) de HemoCue Hb 201 Microcuvettes (an in vitro diagnostic medical device (IVD))

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por HemoCue Australia Pty Ltd.

¿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
    RC-2013-RN-00825-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-08-08
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of hemocue hb 201 microcuvettes, where the foil within the pouch has been damaged. if a single pack pouch is damaged, the microcuvettes can be exposed to moisture the cuvettes will not fill properly and no measurement will be given.
  • Acción
    HemoCue is asking users to discard any affected microcuvettes as per the Instructions for Use. Replacement of affected units can be arranged by consulting HemoCue.

Device

  • Modelo / Serial
    HemoCue Hb 201 Microcuvettes (an in vitro diagnostic medical device (IVD))Lot Numbers: 12086555, 1208660, 1209669, 1209674, 1210688, 1211697, 1301708, 1301717, 1322723, 1303734ARTG Number: 137082
  • Manufacturer

Manufacturer