—#42548

Product

Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #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.

FDA product code: KHO — Fluorometer, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K962919
Affected lot / code info: All Vitros ECi units currently on the market (software version 3.1 or lower).

Why it was recalled

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 negtively biased.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 9/29/2005 issued to all domestic customers of the VITROS ECi/ECiQ systems and to Ortho/J&J foreign affiliates. Customers instructed to immediately discontinue using reflex processing to the VITROS Anti-HBc IgM and VITROS Anti-HAV reagent packs.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14626

Distribution

Distribution pattern: Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.

Timeline

Recall initiated: 2005-09-29
Posted by FDA: 2005-11-15
Terminated: 2007-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42548. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.