Events

Retiro De Equipo (Recall) de ETEST Teicoplanin 256 (TP) SPB and Foam packaging. 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-01530-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-19
  • 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-01530-1
  • 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
    Following an assessment of etest teicoplanin with staphylococcus spp., biomerieux observed an underestimation of mic values by at least 1 dilution for coagulase negative staphylococci (cons); even though the mic essential agreement at +/- 1 dilution is > 95% between etest tp256 and the reference method agar dilution (ad) for staphylococcus spp.This underestimation leads to a risk of false susceptible results linked, in particular to the lack of an intermediate category interpretation if eucast breakpoints are applied for this antibiotic. during the study, the false susceptible rate observed was 37.5% for cons, where strains with an mic at 8 mg/l, by the reference method (resistant) can be found susceptible by etest teicoplanin.
  • Acción
    biomerieux is advising users to stop using ETEST Teicoplanin for testing of CoNS and use an alternative method. The test can continue to be used with other microorganisms. For tests previously performed, users are advised to identify any possible false susceptible results that may have occurred, to analyse the related risks and to determine appropriate actions, if relevant.

Device

ETEST Teicoplanin 256 (TP) SPB and Foam packaging. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ETEST Teicoplanin 256 (TP) SPB and Foam packaging. An in vitro diagnostic medical device (IVD)Reference Number: 412461 & 522018Multiple serial numbers affectedARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd