Events

Retiro De Equipo (Recall) de VITEK 2 Identification / Antimicrobial Susceptibility Test Cards. 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-00523-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-21
  • 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-00523-1
  • 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 have identified a potential issue for specific product lots that is related to the white pouch which contains vitek 2 test cards. the integrity of some of the pouches may be compromised. a compromised test card pouch can impact card reagents due to the entry of moisture. the white pouch is composed of 5 layers of material, 4 of which are clear. all 5 layers must be compromised for a pouch to potentially allow moisture to enter the pouch. based on internal testing, approximately 20% of card pouches exhibited a visual defect, which is a small puncture or tear in the packaging at the "stitch seal". however, 1 in 200 (0.5%) card pouches that passed careful visual inspection failed further integrity tests.The compromised test card pouch integrity could yield false resistance for antibiotics on the ast panel, cause a false negative extended-spectrum beta-lactamase (esbl) test or result in a false positive urea (ure) reaction on id cards.
  • Acción
    bioMérieux is advising users to identify impacted lots and visually inspect the test card pouches on both sides for the defect. The defect is a small puncture or tear in the packaging at the "stitch seal". If the defect is observed, destroy the associated test card(s) and contact bioMérieux for credit or replacement. If the defect is not observed, continue testing as per normal procedure, but increase monitoring for potential testing errors, as visual inspection may not identify all affected ID/AST cards. Repeat testing if you observe results potentially indicative of a pouch defect, as detailed in the customer letter. If concerns exist after repeat testing, alternative methods of establishing drug susceptibility should be used. A look-back of results previously generated with the affected lots is recommended.

Device

VITEK 2 Identification / Antimicrobial Susceptibility Test Cards. An in vitro diagnostic medical ...
  • Modelo / Serial
    VITEK 2 Identification / Antimicrobial Susceptibility Test Cards. An in vitro diagnostic medical device (IVD)Multiple Products and Lot NumbersARTG Numbers: 215320, 196634, 212784
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd