24

Aug

2016

Cl II AB SCIEX QTRAP 4500MD

0

Company: AB Sciex
Date of Enforcement Report 8/24/2016
Class lI:

PRODUCT

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.
Recall Number Z-2529-2016

REASON
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.

RECALLING FIRM/MANUFACTURER
AB Sciex, Framingham, MA on 6/16/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
28 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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Next public offering: TBD