Events

Retiro De Equipo (Recall) de chromID S.aureus agar (SAID/MRSA). 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-2015-RN-00804-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-26
  • 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-00804-1
  • 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
    During an internal investigation, biomérieux observed an anomaly on nine (9) lots of chromid s. aureus manufactured with the same semi-finished lot.This anomaly is causing a delayed colouration of the colonies which appear white/light green instead of green resulting in a potential false negative result. biochemical and/or immunological tests must be performed to identify colonies other than green ones (white, pink or mauve): therefore, the risk of delivering a false negative result is mitigated if the instructions for use have been followed.
  • Acción
    Biomerieux is advising users to discontinue use and discard any remaining inventory of the affected product. Biomerieux advises that users should discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/08/2016.

Device

chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)chromID S.aureus agar (SAID)Lot Numbers: 1004119200, 1004044190, 1004085400chromID MRSA agar / chromID S. aureus agar (MRSA/SAID)Lot Numbers: 1004158090, 1004091980, 1004113000, 1004141170ARTG Number: 182081An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd