Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

FDA: Software Defect May Cause Some Sciex Spectrometers to Incorrectly Assign Test Results

September 1, 2016 By U.S. Food and Drug Administration

FDA Notice Includes:

Sciex API 3200 LC/MS/MS System, 3200MD QTRAP LC/MS/MS System, Triple Quad 4500 LC/MS/MS System, and the QTRAP 4500 LC/MS/MS equipped with:

  • the Analyst Software Versions 1.6.1 and 1.6.2, and
  • the MultiQuant Software Versions 3.0, 3.0.1, and 3.0.2.

AUDIENCE: Risk Manager, Laboratory

ISSUE: The FDA is alerting lab staff and health care professionals about a software defect in Sciex mass spectrometers. This software defect may cause the devices to incorrectly assign results to samples analyzed. Sciex notified the FDA that, under certain conditions, the defect in the software versions identified above may lead the devices to display results that do not match the specimens tested. This is of concern because health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices. A potential inaccurate clinical diagnosis or treatment decision may lead patients to experience serious adverse health consequences.

The mass spectrometers manufactured by Sciex are medical devices specified either for clinical diagnostic use or for research use only (RUO). RUO devices are typically in a development stage and must be labeled “For Research Use Only. Not for use in diagnostic procedures.”

The company has sent Urgent Medical Device Correction Letters and issued two voluntary recalls for the mass spectrometers for clinical use. However, there may be customers of the RUO version of the mass spectrometers that are using them for clinical purposes. Since Sciex has not notified its customers of the RUO version about the issues associated with the software defect in the instruments, we are concerned that these customers, which include clinical laboratories, may be unaware of the issue and its potential impact on results generated by the device.

BACKGROUND: Mass spectrometers are devices used in lab settings to identify inorganic or organic compounds (e.g. lead, mercury, drugs, proteins, and peptides) in human specimens. The devices separate isotopes, molecules, and molecular fragments according to their mass through electric and magnetic fields. Health care professionals may use the results to aid in their clinical diagnosis or to help evaluate possible treatment decisions.

RECOMMENDATION: FDA recommends the following:

  • Determine if your facility owns and uses one of the mass spectrometers equipped with the software listed above;
  • Contact Sciex for necessary software corrections; and
  • If necessary, laboratories should follow CLIA requirements to investigate and take appropriate corrective action when errors have been known, or are suspected to have occurred.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518907.htm

Related Articles Read More >

Biological Toolkit of Cells Assembled Like Legos
New Technology Keeps Eye On Babies’ Movement In The Womb
Robots Won’t Replace Teachers But Can Boost Children’s Education
Artificial Placenta Created In Laboratory
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe