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U.S. Department of Health and Human Services

Class 2 Device Recall enGen Laboratory Automation Systems

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  Class 2 Device Recall enGen Laboratory Automation Systems see related information
Date Initiated by Firm April 10, 2014
Date Posted June 09, 2014
Recall Status1 Open3, Classified
Recall Number Z-1738-2014
Recall Event ID 68270
510(K)Number K063144  
Product Classification Analyzer, Chemistry (photomertic, discrete), for clinical use - Product Code JJE
Product enGen Laboratory Automation Systems (enGen)
with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass. If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.
Code Information TCA Software versions 2.6 , 3.2 and 3.5 configured with Bypass Modules for ADVIA Centaur (R), Abbott Architect (TM), VITROS (R) and/or Tosoh AIA (R) Systems
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ms. Jennifer Paine
Manufacturer Reason
for Recall
Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems.
FDA Determined
Cause 2
Software design
Action Urgent Product Correction Letters (CL2014-114, dated 4/10/2014) were sent to all US customers and Foreign affiliates starting on 4/10/2014. The letter informed customers of the issue and provided required actions to be taken: Routinely monitor your Bypass module(s) -- If you detect a stoppage due to the software timing issue, follow the steps in the How to Detect the Bypass Module Time Issue and Release the Samples section on Page 2 of this notification. -- Complete the Confirmation of Receipt Form and return by 4/23/2014. -- Place this notification near each system or with your enGen (TM) Laboratory Automation System user documentation.
Quantity in Commerce Domestic - 31 units; Foreign - 77 units
Distribution Worldwide Distribution: US Nationwide including Puerto Rico, and countries of: Australia, Bermuda, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.