Events

Retiro De Equipo (Recall) de Sensitest Agar

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-2016-RN-01142-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-02
  • 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-2016-RN-01142-1
  • 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 biomérieux 04134 sensitest agar. the issue is related to the testing of cefoxitin 10µg disc on staphylococcus aureus yielding zones of inhibition of 5.5 to 6.5 annular radius with isolates of methicillin-resistant staphylococcus aureus (mrsa) (confirmed meca positive). in addition, there are also problems with the lawn growth of staphylococcus intermedius which impacts adversely on susceptibility testing of that organism. the size (<8mm) and morphology of the zone should immediately raise suspicion however, the isolates could be reported as susceptible to cefoxitin (methicillin). therefore, there is the potential for underdiagnoses of mrsa.
  • Acción
    As a precautionary measure, BioMérieux is strongly recommending that, as an interim measure while investigations are continuing, to cease using 04134 Sensitest Agar for Staphylococcus sp. and test staphylococci on 04091 Mueller Hinton Agar. It is also recommended that recent results be re-examined using 04091 Mueller Hinton Agar and/or perform MecA testing. Discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. BioMérieux is continuing to investigate the issue in consultation with the Therapeutic Goods Administration (TGA). Further correspondence may be provided following the outcome of the investigations.

Device

Sensitest Agar

Manufacturer

Biomerieux Australia Pty Ltd