Class 2 Device Recall enGen Laboratory Automation System

• Date Initiated by Firm: April 26, 2017
• Create Date: December 14, 2017
• Recall Status: Terminated on August 23, 2021
• Recall Number: Z-0254-2018
• Recall Event ID: 77172
• 510(K)Number: K063144
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: enGen Track System with TCAutomation Software Version 4.2
• Code Information: Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Joe Falvo; 585-453-3452
• Manufacturer Reason for Recall: A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track
• FDA Determined Cause: Software design (manufacturing process)
• Action: On 26 April 2017, Ortho Clinical Diagnostic issued a notice titled "Important Product Correction Notification" and a response form (Ref. CL2017-090) to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all potentially affected enGen customers to inform them of the issue and provide them instructions on how to monitor and correct the issue if it has occurred. Foreign affiliates were informed by email on 26 April 2017 of the issue. Potentially affected customers are those that have enGen Systems with: 1) TCA software V4.2 and configured with Rack Exit Module(s) and/or a Rack Entry & Exit (Combined) Module(s), but not configured with any ES Flex modules, and/or 2) TCA software V4.2 and a Stago analyzer with the Stago STA-R interface. **Required Actions- 1) When checking samples in the Check drawer, do the following based on your enGen System configuration: -For enGen Systems configured with Rack Entry & Exit (Combined) Module or Rack Exit Module without ES Flex, you may observe an increase in Sample IDs (SID) with General Error Duplicate SID in router messages in the Check Window. Remove the samples that are falsely identified as Duplicate SIDs from the Check drawer and reload the sample on the track for further processing if needed. NOTE: Refer to the Question and Answer section on page 3 for how to identify which samples are falsely identified as Duplicate SIDs. - For enGen Systems configured with a Stago analyzer, you may observe and increase in SIDs with "Sample not defined in router" messages for samples returning from the analyzer. Perform all post-analytical processing steps for associated samples, such as recapping, sorting and storing, off-track (manually). 2) Complete and return the attached Confirmation of Receipt form by May 9, 2017. Customers with questions may contact the Technical Solutions Center at 1-800-421-3311, 24 hours per day 7 days per week
• Quantity in Commerce: 16
• Distribution: Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
• 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.