Events

Retiro De Equipo (Recall) de Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501 and c502 modules)

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

¿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-2017-RN-00902-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-27
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00902-1
  • 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
    When the incubation bath is cleaned or cuvettes replaced on the cobas c 501/502 modules during routine monthly maintenance, the usm cover 3 is removed. whilst loosening one of the thumb screws on this cover, an instrument operator cut their thumb on the 90-degree edge of the thumb screw bracket.Given the cobas c 501 modules and cobas c 502 modules share the same hardware, roche diagnostics has, as a precaution, decided to inform and request operators of both systems to perform the related maintenance task with special caution, to prevent any further occurrence.Although the design of the usm cover 3 is according to the manufacturer’s specification, and the 90-degree edge is clearly visible, a medical risk due to an injury cannot be entirely excluded. roche has received only one complaint since this product was launched in 2006. a warning statement will be added to the respective operator manuals specifying the need to perform the related maintenance task with special caution.
  • Acción
    Roche Diagnostics will add a warning statement to the respective operator manuals, which will be available by December 2017.

Device

Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501...
  • Modelo / Serial
    Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501 and c502 modules)Material Number: 05400937001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited