Events

Recall of TRIPLE QUAD 4500MD LC/MS/MS SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AB SCIEX PTE. LTD..

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
    144782
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-23
  • 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
    Sciex is initiating a field action for the multiquant md software versions 3.0 3.0.1 and 3.0.2. multiquant md software is for use with the api 3200md lc/ms/ms system 3200md qtrap lc/ms/ms system triple quad 4500md lc/ms/ms system and qtrap lc/ms/ms system. an issue has been identified with multiquant md software where under certain conditions a user can be presented with incorrect quantitative results when using the sum multiple ions feature.

Device

TRIPLE QUAD 4500MD LC/MS/MS SYSTEM
  • Model / Serial
    Model Catalog: 5031257 (Lot serial: BX20951511); Model Catalog: 5024500 (Lot serial: BU20201504); Model Catalog: 5024501 (Lot serial: BV20701511); Model Catalog: 5031231 (Lot serial: BW20201508)
  • Product Description
    TRIPLE QUAD 4500MD LC/MS/MS SYSTEM;3200MD QTRAP LC/MS/MS SYSTEM;API 3200MD LC/MS/MS SYSTEM;QTRAP 4500MD LC/MS/MS SYSTEM
  • Manufacturer
    AB SCIEX PTE. LTD.

Manufacturer

AB SCIEX PTE. LTD.