Events

Retiro De Equipo (Recall) de VITROS 5,1 FS Chemistry Systems using Software Version 2.8 & Below. 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-2015-RN-00214-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-13
  • 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-00214-1
  • 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, inc. (ocd) has confirmed two instances where a vitros microslide cartridge was misidentified. both instances occurred when an operator accessed slide supply 1 (ss1) before the green indicator light was illuminated and subsequently proceeded to load a slide cartridge into slide supply 2. in each occurrence, the loaded cartridge in slide supply 2 was misidentified.
  • Acción
    If an operator inadvertently accesses a Slide Supply load door before the green indicator light is illuminated and the system generates a TAS-70E or TAS-20E condition code the operator must open and close both Slide Supply doors (Slide Supply #1 & 2), not remove or add any cartridges, and initialise the system. This will cause the system software to scan all slots of both Slide Supplies in order to properly identify the contents. Discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. The resolution to this issue will be contained in the next version of software currently under development. This action has been closed-out on 31/05/2016.

Device

VITROS 5,1 FS Chemistry Systems using Software Version 2.8 & Below. An in vitro diagnostic medica...
  • Modelo / Serial
    VITROS 5,1 FS Chemistry Systems using Software Version 2.8 & Below. An in vitro diagnostic medical device (IVD). Product Codes: 6801375 & 6801890ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics