Events

Retiro De Equipo (Recall) de ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)

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-2018-RN-00090-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-01-30
  • 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-2018-RN-00090-1
  • 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 a study conducted on etest polymyxin b with 180 clinical strains (pseudomonas aeruginosa, acinetobacter and enterobacteriaceae), an underestimation of mics has been observed for pseudomonas aeruginosa and acinetobacter species, compared to those obtained using the broth micro-dilution (bmd) reference method. this has led to false susceptible results when the etest polymyxin b results are interpreted using clsi breakpoints; there are no breakpoints for this drug in the eucast guidelines. as a consequence, etest polymyxin b (ref. 533400 & 533408) blister packaging can no longer be recommended for use with pseudomonas aeruginosa or acinetobacter strains.
  • Acción
    bioMérieux is advising customers to discontinue use of the ETEST Polymyxin B strips to determine the MICs for Pseudomonas aeruginosa or Acinetobacter species. Laboratories can continue to use ETEST Polymyxin B for Enterobacteriaceae species.

Device

ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)
  • Modelo / Serial
    ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)POLYMYXIN B PO 1024 WW B30 Reference Number: 533400Batch Numbers: 1005807890, 100575830, 1005497750, 1005161530, 1004414690POLYMYXIN B PO 1024 WW B100Reference Number: 533408Batch Number: 1004530070ARTG Number: 187139 (Biomerieux Australia Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd