Nov

2005

Ortho-Clinical Diagnostics. Class II

Company: Ortho-Clinical Diagnostics.
Date of Enforcement Report:11/16/2005
Class:lI

PRODUCT
Vitros ECi Immunodiagnostic System, sold as Catalog #863 3893; Catalog #192 2814 (Vitros ECiQ), and Catalog #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units, Recall # Z-0137-06

REASON
When using Vitro ECi Immunodiagnostic System with Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs, results of the 1st of two required re-test replicates may be negatively biased..

CODE
All Vitros ECi units currently on the market (software version 3.1 or lower).

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated September 29, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3,507 Vitros Eci systems

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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Ortho-Clinical Diagnostics. Class II

Amy Sellers

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