20

Jan

2016

Cl II Ortho VITROS 5000 Chemistry System

0

Company: Ortho-Clinical Diagnostics
Date of Enforcement Report 1/20/2016
Class lI:

PRODUCT

VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Recall Number Z-0641-2016

REASON
Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, rochester, NY on 11/3/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
Domestic: 1083, Foreign: 999

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.

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