Events

Retiro De Equipo (Recall) de cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)(for use on the cobas 6800/8800 systems)

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-00744-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-06-08
  • 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-00744-1
  • 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 has observed an increased rate of invalid internal control (ic) results for cobas mpx when used with certain lots of the cobas omni mgp reagent. this issue affects only the blood screening assays, cobas mpx. for the non-blood screening assays, these lots of cobas omni mgp reagent continue to meet specifications, and no performance issues have been identified. the cobas 6800/8800 systems will correctly flag a sample result as invalid if the internal control is invalid. there is no risk of generating incorrect patient results as a consequence of this issue. all previously generated valid results and runs remain valid.
  • Acción
    Roche is advising customers to restrict the use of affected cobas omni MGP Reagent lots to non-blood screening assays only (CMV; CT/NG; HPV), and discontinue the use of these specific lots with the cobas MPX.

Device

cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD...
  • Modelo / Serial
    cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)(for use on the cobas 6800/8800 systems)cobas omni MGP Reagent Material Number: 06997546190Pack Size: 480 testsLot Numbers: W17311, X05638, X05639, X16159ARTG Number: 175163
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited