Z-1738-2014Class II

enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a...

Name: Z-1738-2014 enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a...
Creator: Ortho-Clinical Diagnostics
Published: 2014-04-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-04-10 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for... on 2014-04-10. FDA classified it as Class II and gives the reason as "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...". 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-1738-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-10
Posted: 2014-06-09
Terminated: 2017-03-06
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1738-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1738-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-09

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)