Events

Retiro De Equipo (Recall) de ACL Top Family of analysers used with HemosIL APTT reagent (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 Werfen Australia Pty Ltd.

¿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-00774-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-31
  • 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-00774-1
  • 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
    Werfen australia's investigation of recent customer complaints determined that an acl top family instrument can experience carry-over that causes shortened aptt clotting times on patient and/or quality control results. carry-over can occur when a hemosil synthaasil aptt reagent (pn 0020006800) is located in the same reagent rack as certain other hemosil reagents. the carry-over is introduced during the liquid height check that is performed upon rack insertion and is dependent on material position, the order of rack insertion, and the sequence in which the assays are performed.
  • Acción
    Werfen is providing users with work around instructions to follow to mitigate the potential for this issue to occur. The requirement for a look back at previously reported results should be determined by the laboratory director. A software update is currently under development to correct this issue permanently. This action has been closed-out on 10/02/2016.

Device

ACL Top Family of analysers used with HemosIL APTT reagent (an in vitro diagnostic medical device...
  • Modelo / Serial
    ACL Top Family of analysers used with HemosIL APTT reagent (an in vitro diagnostic medical device (IVD))Models affected: ACL TOP, ACL TOP CTS, ACL TOP 700, ACl TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS and ACL TOP 300 CTSPart Numbers: 00000280000, 00000280010, 00000280020, 00000280030, 00000280040, 00000280050 and 00000280060ARTG Number: 197892, 98770
  • Manufacturer
    Werfen Australia Pty Ltd

Manufacturer

Werfen Australia Pty Ltd