Events

Retiro De Equipo (Recall) de ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 698110 & 696133

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-2015-RN-00157-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-03-06
  • 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-2015-RN-00157-1
  • 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
    Internal investigations by roche diagnostics verified that the within run precision (cv) for the positive/negative control with different reagent lots is approximately 10%. the specification is lower than 8%. patient sample results which are very close to the cutoff might recover below the cutoff. the affected reagent lots expire in may 2015. newer lots are not affected by the precision issue and can be used as a replacement.
  • Acción
    Roche is requesting their customers to discard any remaining stock of THC II from reagent lots 69811301 and 60419501. This action has been closed-out on 02/03/2016.

Device

ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 69...
  • Modelo / Serial
    ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 698110 & 696133 ARTG number: 174911
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited