Events

Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products HBsAg Controls. 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 Ortho-Clinical Diagnostics.

¿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-2016-RN-00874-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-04
  • 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-2016-RN-00874-1
  • 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
    Ortho clinical diagnostics have received customer complaints that the signal/cutoff (s/c) results have increased when using the negative control. their investigation confirmed that results generated using these lots of negative controls had a positive shift in mean results (s/c) as the product approached its open-reconstituted 5 day limit. increased results (s/c) may also be observed with the positive control.This issue is isolated to vitros hbsag controls. patient sample results generated using vitros immunodiagnostic products hbsag/hbsag es reagents are not affected.
  • Acción
    Ortho Clinical Diagnostics is advising users to discontinue using and discard the affected lots. If you do not have an alternative unaffected lot, continue using the affected lot(s) following these instructions: - Control results must be within acceptable limits on the day of reconstitution (Day 1). - Store open-reconstituted vials frozen for up to 4 weeks. We recommend that you aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used. - Upon receipt of replacement order, discard all remaining inventory. This action has been closed-out on 22/02/2017.

Device

VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).Product Code: 6800598Lot Numbers: 0860, 0870, 0880, 0890, 0908ARTG Number: 251956
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics