Events

Retiro De Equipo (Recall) de Elecsys CMV IgM assay (04784618190) - Diluent Universal. 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-2015-RN-00120-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-12
  • 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-00120-1
  • 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 investigation results by roche diagnostics confirmed that certain lots of diluent universal may have an influence on the cmv igm results and may lead to low or false negative results with two lots of the elecsys cmv igm assay. roche confirmed that a specific component used in the diluent universal caused the signal reduction of an internal control sample in the elecsys cmv igm assay. this internal control sample showed a high reactivity against one of the three specific antigens included in the cmv igm assay. the signal reduction has only minor effects on the calibrators and controls (precicontrol cmv igm) and therefore is likely to remain undetected, resulting in false non-reactive cmv igm results and undetected acute cmv infections. in summary, there is a reasonable probability that the use of affected diluent lots may lead to delayed or incorrect diagnosis and/or treatment of acute cmv infection.
  • Acción
    Roche Diagnostics is requesting the customers to discard all current stocks of affected Diluent Universal and replace with the Diluent Universal (11732277122 - LOT 181121) that has been shipped to the laboratories free of charge. Roche Diagnostics is further requesting laboratories to review the Negative Elecsys CMV IgM patient samples tested between 1st November 2014 and receipt of this notice, whose results fell within the COI range of 0.5-0.7 COI and were obtained using one of the Diluent Universal lots and recommending appropriate patient re-testing with the new diluent lot provided. This action has been closed-out on 17/08/2016.

Device

Elecsys CMV IgM assay (04784618190) - Diluent Universal. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Elecsys CMV IgM assay (04784618190) - Diluent Universal. An in vitro diagnostic medical device (IVD)Lot Numbers: 03183971122 and 11732277122Supplied since 1st November 2014
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited