Class 2 Device Recall enGen (TM) Laboratory Automation System

• Date Initiated by Firm: March 20, 2014
• Date Posted: June 02, 2014
• Recall Status: Terminated on April 11, 2017
• Recall Number: Z-1677-2014
• Recall Event ID: 68263
• 510(K)Number: K063144
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest ---; ; Background: 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.
• Code Information: enGen (TM) Laboratory Automation Systems Configured with enGen (TM) Select or Custom (TM) v3.2.2 and below with Data Innovations, LLC Instrument Manager (TM) v8.06 with Data Innovations, LLC TCA Driver v8.04.0020 and below
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Ms. Jennifer Paine; 908-218-8776
• Manufacturer Reason for Recall: Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.
• FDA Determined Cause: Software design
• Action: US consignees were sent Urgent Product Correction Letters (Cl2014-102, dated 3/20/2014) on 3/20/2014 by FedEx or USPS (for PO Box addresses only) overnight mail, informing them of the issue and instructing them to ensure that all required data elements are entered and in the correct format when using the auto verification feature or custom rules. J&J Foreign affiliate consignees were notified by e-mail on 3/20/2014 informing them of the issue.
• Quantity in Commerce: Domestic: 20 units, Foreign: 61 units
• Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the 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 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.