Events

Retiro De Equipo (Recall) de Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). 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-2014-RN-00159-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-13
  • 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-2014-RN-00159-1
  • 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 identified that the affected etest strips do not give the correct minimum inhibitory concentration (mic) for some quality control strains, with the mic results out of range (high) according to the mic specification described in the quality control procedure.The mic results conformed at the time of batch release however investigations have confirmed this issue appears over time, leading to a performance issue by overestimating the mic.
  • Acción
    bioMerieux is advising users to discontinue use and destroy affected stock. Replacement kits will be provided once a new batch is available.

Device

Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). An in vitro diagn...
  • Modelo / Serial
    Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). An in vitro diagnostic medical device (IVD)Product Reference Number:531618Lot Number: 1002054430Reference /Lot Number inside packaging: 51103168, 1001897090Product Reference Number: 531610Lot Number: 1000853690, 1001960650Reference /Lot Number inside packaging: 51103610, 1001895910, 51103160, 1001895910Product Reference Number: 412332Lot Number: 1002110560, 1002389880ARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd