Events

Rappel de WATERS MASS SPECTROMETER - ACQUITY TQD IVD

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par WATERS CORPORATION.

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
    30897
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-10-17
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 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 a short term loss of or variation in sensitivity that may subsequently lead to inaccurate data. the loss of or variation in sensitivity is most pronounced in assays with shorter dwell times (i.E. less than 100 ms) and may not be detected by quality control and internal standard value monitoring.

Device

WATERS MASS SPECTROMETER - ACQUITY TQD IVD
  • Modèle / numéro de série
    Model Catalog: 186003875IVD (Lot serial: QBB1290); Model Catalog: 186004490IVD (Lot serial: VBA521); Model Catalog: 186003875IVD (Lot serial: QBB1147); Model Catalog: 186003875IVD (Lot serial: QBB1122); Model Catalog: 186003875IVD (Lot serial: QBB1050); Model Catalog: 186004490 (Lot serial: VBA607); Model Catalog: 186004490 (Lot serial: VBA200); Model Catalog: 186004490 (Lot serial: VBA198); Model Catalog: 186004490 (Lot serial: VBA066); Model Catalog: 186004490 (Lot serial: VBA021); Model Catalog: 186003875 (Lot serial: QBB1227); Model Catalog: 186003875 (Lot serial: QBA625); Model Catalog: 186003875 (Lot serial: QBA613); Model Catalog: 186003875 (Lot serial: QBA546); Model Catalog: 186003875 (Lot serial: QBA427); Model Catalog: 186003875 (Lot serial: QBA369); Model Catalog: 186003875 (Lot serial: QBA327); Model Catalog: 186003875 (Lot serial: QBA122D); Model Catalog: 186003250 (Lot serial: VAB807); Model Catalog: 186003250 (Lot serial: VAB488); Model Catalog: 186003250 (Lot serial: VAB451); Model Catalog:
  • Description du dispositif
    Acquity TQD IVD Mass Spectrometer
  • Manufacturer
    WATERS CORPORATION

Manufacturer

WATERS CORPORATION