Sep

2014

Cl II AB SCIEX API 3200MD” LC/MS/MS System

Company: Ab Sciex
Date of Enforcement Report: 9/17/2014
Class lI:

PRODUCT

AB SCIEX API 3200MD” LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543. Recall Number Z-2609-2014

REASON
Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis

RECALLING FIRM/MANUFACTURER
Ab Sciex, Framingham, MA on 7/15/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
6 Units

DISTRIBUTION
FL, NC, OK, PA, TX

___________________________________

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.

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Cl II AB SCIEX API 3200MD” LC/MS/MS System

Amy Sellers

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