Events

Safety Alert for Mass Spectrometry Instruments

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Waters Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-10-24
  • Event Date Posted
    2012-10-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121024a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: waters corporation mass spectrometry instruments medical device manufacturer, waters corporation, has initiated a medical device field safety corrective action concerning various models of mass spectrometry instruments. the affected models can be identified as follows:- waters acquity tqd; acquity sqd; lct premier xe; quattro premier; quattro premier xe; quattro micro; xevo g2 tof; xevo tq; xevo tqd & zq 2000 the manufacturer initiated this voluntary medical device correction because 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 always be detected by quality control and internal standard value monitoring. no adverse events have been reported as a result of this potential issue. according to the manufacturer, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 october 2012.

Device

Mass Spectrometry Instruments
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Waters Corporation Mass Spectrometry Instruments
  • Manufacturer
    Waters Corporation

Manufacturer

Waters Corporation