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Class 2 Device Recall enGen Laboratory Automation System |
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Date Initiated by Firm |
October 08, 2013 |
Date Posted |
February 09, 2014 |
Recall Status1 |
Terminated 3 on April 11, 2017 |
Recall Number |
Z-0941-2014 |
Recall Event ID |
66467 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product |
enGen Track System with enGen Select v5.0 with autoverification enabled
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 |
Autoverification and Custom Rules for enGen Laboratory Automation Systems using enGenTM Select v5.0 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 100 Indigo Creek Dr Rochester NY 14626-5101
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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.
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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 |
8 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
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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.
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