Events

Retiro De Equipo (Recall) de Haemophilus Test medium (HTM). 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 Biomerieux 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-2017-RN-00831-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-03
  • 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-2017-RN-00831-1
  • 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
    Biomérieux have received reports regarding an issue with the use of the 04054 haemophilus test medium. (lot number hdk-206). the issue is related to the media not supporting the growth of haemophilus influenza isolates (atcc 49766 and atcc 49247).
  • Acción
    bioMérieux is requesting Customers cease using lot number HDK-206 (04054 Haemophilus Test medium). It is also recommended that results which have an ongoing clinical impact be re- examined using a different lot number of 04054 Haemophilus Test medium. Distribute this information to all appropriate personnel in your laboratory including others to whom you may have transferred the product, retain a copy in your files. 2. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. 3. Quarantine inventory of 04054 Haemophilus Test medium (HTM) for Lot # HDK-206 and discard all affected products in an appropriate manner. Please complete and return the acknowledgement form to qa.anz@biomerieux.com to confirm receipt and credit.

Device

Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)Product Number: 04054Lot Number: HDK-206ARTG Number: 201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd