Events

Retiro De Equipo (Recall) de Etest COLISTIN CO 256 WWEtest COLISTIN CO 256 WW B30

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-01008-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-07-29
  • 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-01008-1
  • 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 has been alerted via a european committee on antimicrobial susceptibility testing (eucast) warning letter about potential underestimation of the minimum inhibitory concentration (mic) values for enterobacteriaceae and acinetobacter when using the etest colistin gradient test. there is potential to obtain false susceptible results.Biomérieux have initiated a complaint investigation. the investigations are on-going, with the following identified to date:- etest colistin performance depends on the mueller hinton agar plate used. - for enterobacteriaceae strains, the performance conforms if used in conjunction with the mhe agar (from biomérieux) with a good concordance rate compared to broth-micro dilution method.- there is a potential of false susceptible results on etest colistin with some mueller hinton agar (except with the mhe agar from biomérieux for the enterobacteriaceae strains).
  • Acción
    bioMérieux is advising users that for Enterobacteriaceae strains, to can continue to use Etest COLISTIN for diagnostic purposes, only if it is used with MH-E agar (Mueller Hinton-E agar from bioMérieux Ref. 413822-or the soon to be launched 04091 MHE agar in October 2016)). If not, or if strains other than Enterobacteriaceae are tested, bioMérieux recommend users restrict its use to epidemiological surveys. Among tests previously performed, it is recommended users identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant.

Device

Etest COLISTIN CO 256 WWEtest COLISTIN CO 256 WW B30
  • Modelo / Serial
    Etest COLISTIN CO 256 WWEtest COLISTIN CO 256 WW B30Catalogue Number: 537300Etest COLISTIN CO 256 WW B100Catalogue Number: 537308Multiple Lot Numbers affected (see attached)ARTG Number: 187139An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd