Jan

2015

Cl II VITROS 3600

Company:Ortho-Clinical Diagnostics
Date of Enforcement Report: 1/21/2015
Class lI:

PRODUCT

VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD — Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recall Number Z-0967-2015

REASON
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration..

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 11/19/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
658 total: USA – 144, Foreign – 514

DISTRIBUTION
Nationwide 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 VITROS 3600

Amy Sellers

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