Events

Retiro De Equipo (Recall) de cobas 4800 PCR Media Kit, cobas 4800 PCR Urine Sample Kit and cobas PCR Female Swab Kit. 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-2013-RN-01363-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-24
  • 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-2013-RN-01363-1
  • 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 diagnostics australia would like to inform users of the possibility of leakage occurring for some batches of cobas® pcr media ivd. these are packaged into different lots via the cobas pcr urine ivd kits and cobas pcr female swab ivd kits.
  • Acción
    Roche is requesting their customers to continue to follow the instructions for use and to inspect each tube or blister pack for evidence of leakage. If leakage is detected the media must be discarded.

Device

cobas 4800 PCR Media Kit, cobas 4800 PCR Urine Sample Kit and cobas PCR Female Swab Kit. An in vi...
  • Modelo / Serial
    cobas 4800 PCR Media Kit, cobas 4800 PCR Urine Sample Kit and cobas PCR Female Swab Kit. An in vitro diagnostic medical device (IVD)Part Numbers/lot numbers: 05170486190/S01885 & earlier (except S01884) and 05170516190/S10487 & earlier
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited