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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS ECiQ Immunodiagnostic System

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  Class 2 Device Recall VITROS ECiQ Immunodiagnostic System see related information
Date Initiated by Firm August 24, 2011
Date Posted January 27, 2012
Recall Status1 Terminated 3 on May 09, 2017
Recall Number Z-0924-2012
Recall Event ID 60847
510(K)Number K962919  
Product Classification Fluorometer, for clinical use - Product Code KHO
Product VITROS¿ ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS¿ ECiQ 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
Code Information Serial Numbers between 30003000 and 30005177; All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ 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 B-hCG is not processed on all systems worldwide.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626
For Additional Information Contact Jennifer Payne
908-218-8190
Manufacturer 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¿ B-hCG II Reagent Packs, Lots 0484 and above.
FDA Determined
Cause 2		 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: 906, Foreign: 1294
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KHO and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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