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U.S. Department of Health and Human Services

Class 2 Device Recall enGen Laboratory Automation System

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  Class 2 Device Recall enGen Laboratory Automation System see related information
Date Initiated by Firm October 08, 2013
Date Posted February 09, 2014
Recall Status1 Terminated 3 on April 11, 2017
Recall Number Z-0942-2014
Recall Event ID 66467
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product enGen Track System with enGen Custom v3.2.2 (& below)

Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
Code Information Custom v3.2.2 & Below Configuration Files
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall
Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
FDA Determined
Cause 2
Software design
Action Ortho Clinical Diagnostics (OCD), issued an Urgent Product Correction Notification letter dated October 7, 2013 and on December 17, 2013 to their customers via Federal Express or via US Postal Service. The letter identified the affected product, problem and actions. The notices advise the customers to ensure that all required data elements are entered and in the correct format if using the autoverification or custom rules for the referenced enGen Laboratory Automation Systems. OCD trained service representatives will contact all affected customers. Customers with questions may call the Customer Technical Service at 1-800-421-3311.
Quantity in Commerce 20 units
Distribution Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK
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.