Dec

2017

Cl II enGen Track System

Company:Ortho-Clinical Diagnostics
Date of Enforcement Report 12/20/2017
Class lI:

PRODUCT

enGen Track System with TCAutomation Software Version 4.2
Recall Number Z-0254-2018

REASON
A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 4/26/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
16

DISTRIBUTION
GA, IL, MO, NC & NY and Internationally

___________________________________

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 enGen Track System

Amy Sellers

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