Z-0137-06

Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059...

Name: Z-0137-06 Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059...
Creator: Ortho-Clinical Diagnostics
Published: 2005-09-29
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2005-09-29 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros... on 2005-09-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0137-06
Status: Terminated
Initiated: 2005-09-29
Posted: 2005-11-15
Terminated: 2007-07-31
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: 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.
FDA 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 in commerce: 3,507 Vitros ECi units distributed
Distribution: Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
Product codes and lots: All Vitros ECi units currently on the market (software version 3.1 or lower).

Product code KHO

K962919Class IVitros Immunodiagnostic SystemJohnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)