Z-0942-2014Class II

enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM...

Name: Z-0942-2014 enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM...
Creator: Ortho-Clinical Diagnostics
Published: 2013-10-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-10-08 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use... on 2013-10-08. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend...". 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-0942-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-08
Posted: 2014-02-09
Terminated: 2017-04-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: enGen Track System with enGen Custom v3.2.2 (& below) Product 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics (OCD), issued an Urgent Product Correction Notification letter dated October 7, 2013 and on December 17, 2013 to their customers via Federal Express or via US Postal Service. The letter identified the affected product, problem and actions. The notices advise the customers to ensure that all required data elements are entered and in the correct format if using the autoverification or custom rules for the referenced enGen Laboratory Automation Systems. OCD trained service representatives will contact all affected customers. Customers with questions may call the Customer Technical Service at 1-800-421-3311.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK
Product codes and lots: Custom v3.2.2 & Below Configuration Files

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0942-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0941-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-08
Z-0942-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-08

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)