Events

Retiro De Equipo (Recall) de Horse Blood Agar. 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-2018-RN-00353-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-05-02
  • 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-00353-1
  • 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 an issue at their brisbane culture media manufacturing site regarding product reference number 04059, lot number jcu-203, horse blood agar. during post release testing a potential contamination issue (contaminated deep and surface) has been identified. the microorganism was identified as a gram positive bacilli.
  • Acción
    bioMérieux is requesting that Laboratories should: 1.Stop using HBA ref. 04059, Lot JCU-203 and segregate the product and discard/dispose appropriately under the relevant laboratory guidelines; 2.Complete and return Attachment A from the customer letter to qa.anz@biomerieux.com in order to confirm receipt; and 3.Contact your local bioMérieux representative for product compensation as necessary.

Device

Horse Blood Agar. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Horse Blood Agar. An in vitro diagnostic medical device (IVD)Reference Number: 04059Lot Number: JCU-203ARTG Number: :201986
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd