Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2012-RN-01068-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01068-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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