Events

Retiro De Equipo (Recall) de Oxoid AST Disc - Ceftazidime CAZ10. 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 Thermo Fisher Scientific Australia & New Zealand.

¿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-01190-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-13
  • 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-2017-RN-01190-1
  • 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
    An internal technical investigation by oxoid, part of thermo fisher scientific, has confirmed that the concentration of antibiotic in thermoscientific oxoid caz10 ceftazidime, ct1629b (specific lots) may decrease over shelf life if not stored frozen. specifically, antibiotic degradation has been identified in product stored at 8°c between 2 and 3 years of shelf life. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for ceftazimide.
  • Acción
    1. Users are to inspect stocks and remove from further use all units from the nominated batch number, then complete the supplied Facsimile Reply Form a for a credit note to be issued. 2. Complete the supplied facsimile Reply Form even if there is no remaining stock subject to recall, so as to reconcile this process.

Device

Oxoid AST Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Oxoid AST Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)Product Code: CT1629BLot Numbers: 1883326, 1849729, 1814258, 1786239, 1752930, 1728103, 1683346, 1646438, 1611709, 1571939, 1562018, and 1558378ARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand