Events

Retiro De Equipo (Recall) de Sample Probe Connector used with cobas modules. 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 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-00398-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-31
  • 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-00398-1
  • 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
    Roche has identified that in very rare cases, a disturbance of the sample liquid level detection (lld) may occur due to a fretting corrosion on the sample probe connector. in such instances, the affected sample probe may not aspirate the sample material at the correct level; accordingly the probe may not be washed adequately, resulting in the possibility of sample carryover.This issue, which was detected during an internal investigation, was caused by a production change in the sample probe connector type, potentially causing fretting corrosion on the sample probe connector. to date, roche have not received any complaints about this issue.
  • Acción
    Roche is requesting that customers check the sample probe in use in their analyser to determine if the sample probe is from the potentially affected serial/lot numbers. If so, customers are advised to contact Roche to discuss an exchange. Until the sample probe is exchanged, users are requested to follow the detailed instructions provided in the customer letter.

Device

Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD)Probe SampleMaterial Number: 04547241001Systems affected: cobas c 501/502/701/702 modulesSample ProbeMaterial Number: 04945794001Systems affected: cobas 8000 ISE module 1800Multiple Serial NumbersARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited