Events

Retiro De Equipo (Recall) de FB Reagent, ZYM B Reagent, API Listeria and API NHFB Reagent

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-00293-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-13
  • 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-00293-1
  • 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
    During the quality control of new lot of fb reagent, a visual defect (colour issue) was observed. the first investigation performed by the manufacturing site showed that this visual defect is due to a specific lot of raw material used for the manufacturing of this fb reagent. in addition, this lot of raw material has also been used for the manufacturing of several lots of fb reagent and zym b reagent using the same raw material than the fb reagent. as the involved lots of zym b reagent are included inside of api nh and api listeria kits, the both references are also impacted.
  • Acción
    BioMeriuex is requesting their customers to discontinue use and discard any stock with visual defects. Testing using the affected lost can continue if daily QC is run using a validated ATCC strain.

Device

FB Reagent, ZYM B Reagent, API Listeria and API NHFB Reagent
  • Modelo / Serial
    FB Reagent, ZYM B Reagent, API Listeria and API NHFB ReagentReference Number: 70562ZYM B reagentReference Number: 70493API NHReference Number: 10400API ListeriaReference Number: 10300Multiple lot numbers affected
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd