Events

Recall of Device Recall AB SCIEX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ab Sciex.

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
    74520
  • Event Risk Class
    Class 2
  • Event Number
    Z-2529-2016
  • Event Initiated Date
    2016-06-16
  • Event Date Posted
    2016-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147818
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mass spectrometer, clinical use - Product Code DOP
  • Reason
    Multiquant md software where under certain conditions a user can be presented with incorrect quantitative results when using the sum multiple ions feature.
  • Action
    AB SCIEX issued recall notification by letter dated June 16, 2016, to all affected customers. The letter identified the problem, provided temporary measures until a permanent software is available. A response form was to be completed and returned. questions regarding this notice contact SCI EX at +1 289 982 2712.

Device

Device Recall AB SCIEX
  • Model / Serial
    Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
  • Product Description
    AB SCIEX QTRAP¿ 4500MD LC/MS/MS System || Mass Spectrometer for In-Vitro Diagnostic Use. || Instrument Part Number (REF): 5031231 || 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
  • Manufacturer
    Ab Sciex

Manufacturer

Ab Sciex
  • Manufacturer Address
    Ab Sciex, 500 Old Connecticut Path, Framingham MA 01701-4574
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA