Z-0923-2012

VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System...

Name: Z-0923-2012 VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System...
Creator: Ortho-Clinical Diagnostics
Published: 2011-08-24
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2011-08-24 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System -- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive... on 2011-08-24. The reason FDA records is "Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0923-2012
Status: Terminated
Initiated: 2011-08-24
Posted: 2012-01-27
Terminated: 2017-05-09
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System -- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid Dilution (ID) code. The diluted results were inconsistent with results from the neat (undiluted) sample, which was within the measuring range of 2.39 - 15,000 mIU/mL. OCD's investigation determined it is possible to obtain negatively biased results if samples are diluted and tested on the VITROS ECi/ECiQ System using VITROS Total B-hCG II Reagent Packs, Lots 0484 and above.
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics (OCD) sent an URGENT Product Correction Notification letter dated August 24, 2011 via FedEx overnight letter to all US consignees with VITROS ECi/ECiQ Systems. Foreign Affiliates were also notified of the problem on August 24, 2011. The letters provided information regarding the affected product, the problem, the actions to be followed prior to reporting results from their laboratory and a Question and Answer Section. Customers were instructed to 1) Post the enclosed Procedure for Reviewing VITROS Total B-hCG II Results near the VITROS ECi/ECiQ System to advise operators of this issue and assist them in reviewing results from diluted samples; 2) Users should consult with their Laboratory Medical Director and request a physician to resolve any concerns users may have regarding previously reported results from Lots 0484 and above of VITROS Total B-hCG II Reagent Packs; 3) Complete and return the attached Confirmation of Receipt form upon receipt of this notification; and 4) Forward the information in this notification if you have distributed this product outside of your facility. For additional questions contact OCD Customer Technical Services at 1-800-421-331.
Quantity in commerce: Domestic: 808; Foreign: 1113
Distribution: Worldwide Distribution - USA (nationwide) and including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Product codes and lots: Serial Numbers between 30000127 and 30002743. All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ Total B-hCG II (human chorionic gonadotropin) Reagent Packs is processed are affected by this correction. --- Note: All systems that are installed worldwide have Software Version 3.8 or lower installed on them, but Total B-hCG is not processed on all systems worldwide.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)