Events

Recall of WATERS MASS SPECTROMETER - ACQUITY TQD IVD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WATERS CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30897
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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:
  • Product Description
    Acquity TQD IVD Mass Spectrometer
  • Manufacturer
    WATERS CORPORATION

Manufacturer

WATERS CORPORATION