Z-0254-2018Class II

enGen Track System with TCAutomation Software Version 4.2

Name: Z-0254-2018 enGen Track System with TCAutomation Software Version 4.2
Creator: Ortho-Clinical Diagnostics
Published: 2017-04-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-04-26 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of enGen Track System with TCAutomation Software Version 4.2 on 2017-04-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0254-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-26
Posted: 2017-12-14
Terminated: 2021-08-23
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: enGen Track System with TCAutomation Software Version 4.2
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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
Root cause tag: software
FDA root 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
Product codes and lots: Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0254-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0254-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-14

Product code JJE

K063144Class IVitros 5,1 Fs Chemistry System with Engen Laboratory Automation SystemOrtho-Clinical Diagnostics, Inc. / cleared 2006-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)