Events

Retiro De Equipo (Recall) de ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.

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-00470-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-08
  • 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-00470-1
  • 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 biomérieux investigation has confirmed a potential performance issue on strain categorization for streptococcus viridans group and streptococcus pneumoniae based on 2017 clsi and eucast breakpoints, which could lead to false susceptible result instead of resistant results on etest etp32 blister packaging when comparing to the broth-micro dilution (bmd) reference method.
  • Acción
    bioMérieux is advising customers who use the 2017 CLSI and 2017 EUCAST clinical guidelines that they can continue the use of ETEST ETP32 blister packaging except for Streptococci group including S. pneumoniae strains. bioMérieux is also advising that laboratories should identify any possible false Susceptible results from previously performed tests and analyse the related risks and determine appropriate actions if relevant.

Device

ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial sus...
  • Modelo / Serial
    ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.Reference Number: 531600 Multiple Lot NumbersARTG Number:187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd