Class 2 Device Recall enGen (TM) Laboratory Automation System

• Date Initiated by Firm: April 17, 2014
• Date Posted: June 10, 2014
• Recall Status: Terminated on April 11, 2017
• Recall Number: Z-1741-2014
• Recall Event ID: 68269
• 510(K)Number: K063144
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest ---; ; 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.). ---The enGen (TM) 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 (TM) 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. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory, the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System, the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing, the sample remains on the track system in the Buffer module while waiting for the test results to be generated. If all test results are generated as expected and no additional actions are required, the sample is routed to a designated Exit module where it can be removed from the track system by the user. However, there are certain situations in which a follow-up action (retest of the sample) may be necessary. In these situations, the sample is routed back to a clinical analyzer via the Bypass module to complete the follow-up action. Examples of situations requiring a retest include, but are not limited to: repeat testing when a "No Result"is generated during the initial test event, sample dilution when an out of range result is obtained during the initial test event, and routing to an alternate analyzer when the first analyzer the sample is sent to is unavailable for testing. Once the follow-up sample metering actions are complete, the sample is routed to Buffer module where it remains until testing is complete. Once all test results are obtained the sample is routed to the designated Exit module.
• Code Information: enGen (TM) Laboratory Automation Systems configured with TCAutomation" Software version 3.5
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• Manufacturer Reason for Recall: Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
• FDA Determined Cause: Software Design Change
• Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On April 17, 2014, foreign affiliates were informed by e-mail of the issue and instructed to notify their customers of the issue and actions. The letters instruct customers: to ensure that samples prematurely routed to Check are detected and processed appropriately, please monitor completion of all pending tests following standard laboratory practice. Customers were informed of the issue and advised to: -- Routinely monitor pending result reports from your Laboratory Information System (LIS) to determine if results are pending for samples. -- Investigate to determine the next action identified for a sample if the sample is routed to the Check location prematurely. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.
• Quantity in Commerce: Domestic: 6 units, Foreign: 3 units
• Distribution: Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy.
• 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 = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.