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
