Events

Retiro De Equipo (Recall) de Various mass spectrometers - Quattro micro, ACQUITY TQD, Quattro Premier XE, Xevo TQ; In vitro diagnostic medical devices (IVD's)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-2012-RN-01068-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-22
  • 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-2012-RN-01068-1
  • 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
    There is a possibility that the ion block source heater may fail. in some instances, the failure could cause short term loss or variation of sensitivity that may subsequently lead to inaccurate data. the loss of or variation in sensitivity is most pronounced in assays with shorter dwell times and may not always be detected by quality control and internal standard value monitoring.
  • Acción
    Customers to contact their Waters field service engineer to order a replacement part (ion block source heater).

Device

Various mass spectrometers - Quattro micro, ACQUITY TQD, Quattro Premier XE, Xevo TQ; In vitro di...
  • Modelo / Serial
    Various mass spectrometers - Quattro micro, ACQUITY TQD, Quattro Premier XE, Xevo TQ; In vitro diagnostic medical devices (IVD's)Quattro microPart:VB-QMicroSerial Numbers:QAA1167, QAA412, QAA742, QAA65, QAA765, QAA802 & QAA836ACQUITY TQDPart:186003875Serial Numbers:QBA470, QBB795, QBB924 & QBB928Quattro Premier XEPart:186003250Serial Numbers:VAB1000, VAB1215, VAB610, VAB844, VAB845 & WAB998Xevo TQPart:186004490Serial Numbers: VBA626 & VBA744ARTG Number: 201727
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia