Events

Retiro De Equipo (Recall) de OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. 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 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-2018-RN-00291-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-03
  • 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-00291-1
  • 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 limited, part of thermo fisher scientific, has confirmed that the performance of antibiotic in thermoscientific oxoid ct1412b cpo30 cefpirome may decrease when stored over 2°c after 24 months. the product has a registered shelf life of 36 months. performance remains unaffected throughout shelf life when stored at -20°c to +2°c. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for cefpirome.
  • Acción
    Thermo Fisher is advising customers to inspect stock for affected product and remove them from further use. Users should destroy/discard all current and unused stock of the affected batches.

Device

OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device.
  • Modelo / Serial
    OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device. Lot Numbers:1611705, 1693625ARTG Number: 208273Thermo Fisher Scientific Australia & New Zealand - Antimicrobial susceptibility testing IVDs
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand