Events

Retiro De Equipo (Recall) de VerifyNow Aspirin Test Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por In Vitro Technologies 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-2015-RN-01252-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-22
  • 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-01252-1
  • 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
    A limited number of kits may result in excessive sample leakage out of the test device cartridge. if this occurs, the verifynow performance results are not affected as the leakage occurs "downstream" of where the reaction occurs and operators are protected by the universal precautions for blood products; however, the instrument can potentially be affected.
  • Acción
    In Vitro Technologies is advising users to inspect stock and quarantine affected batches for return and replacement with unaffected stock. In Vitro Technologies is advising users to perform a EQC test. This action has been closed-out on 04/05/2017.

Device

VerifyNow Aspirin Test Kit
  • Modelo / Serial
    VerifyNow Aspirin Test KitItem Number: ACD85053Lot Number : WH0204ARTG Number: 215577 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd