Events

Retiro De Equipo (Recall) de RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (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 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-2015-RN-00063-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-25
  • 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-2015-RN-00063-1
  • 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
    Iris international (the manufacturer) has received reports of uncontained debris (part fragments) as a result of rotor breakage and lid failures on similar centrifuge models which use the rt12 rotor and shield. a shield was implemented on similar models and this notification is to inform ssmp users that the shield must be used when operating the centrifuge. there have been no reports of the statspin mp centrifuge failing to contain debris when users operate statspin mp centrifuges according to the statspin mp operator’s manual (doc # 55-001806-001) and rt12 tube rotor instructions (doc # 54-006155-001).
  • Acción
    ThermoFisher is providing additional maintainance instructions and updated operators manual. The information included is intended to supplement the current SSMP Operator Manual.

Device

RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)
  • Modelo / Serial
    RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)RT12 Tube Rotor-Kit (RT12) Catalogue Number: RT12-KIT (REF x00-006152-001), Product Labeling: 54-006155-001StatSpin MP Centrifuge Catalogue Number: SSMP (REF x00-004998-001), Product Labeling: 55-001806-001HAll Serial Numbers
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd