Recall Z-0137-06 ยท KHO Fluorometer, For Clinical Use
Ortho-Clinical Diagnostics
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.
| Date | Nov 15, 2005 (initiated Sep 29, 2005) |
| Status | Terminated |
| 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 negtively biased. |
| Root cause | Other |
| Action | 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. |
| Quantity | 3,507 Vitros ECi units distributed |
| Distribution | Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM Johnson & Johnson Clinical Diagnostics, Inc., Oct 18, 1996 |