Feb

2018

Cl II Roche Cobas 8000 Modular Series

Company: Roche Diagnostics Corporation
Date of Enforcement Report 2/28/2018
Class lI:

PRODUCT

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Recall Number Z-0675-2018

REASON
A software failure may incorrectly set the system settings to “default” settings, creating a risk of incorrect results.

RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corporation, Indianapolis, IN on 4/28/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
399

DISTRIBUTION
Nationwide and Puerto Rico

___________________________________

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 Roche Cobas 8000 Modular Series

Amy Sellers

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