Z-2143-2016Class III

enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and...

Name: Z-2143-2016 enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and...
Creator: Ortho-Clinical Diagnostics
Published: 2016-05-16
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-05-16 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD on 2016-05-16. FDA classified it as Class III and gives the reason as "If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends...". 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-2143-2016
Classification: Class III
Status: Terminated
Initiated: 2016-05-16
Posted: 2016-07-08
Terminated: 2018-06-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?. The difference in terminology exists for US Markets only.
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter dated May 16, 2016, to all affected customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by e-mail to subscribers of ORTHO PLUS e-Communications to advise them of the issue and the required actions . Required Actions: 1. Use the numerical test results to assess actions to be taken for these assays, per the IFU. 2. Post this notification by your enGen System or with your user documentation. 3. Complete and return the Confirmation of Receipt form by 25 May 2016. with the Instructions for Use (IFU) directions). If you have any questions regarding this notification, please call the Ortho Technical Solutions Center at any time at 1-800-421-3311.
Quantity in commerce: US: 30 units
Distribution: Nationwide
Product codes and lots: Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; Serial Numbers/J Numbers: JIM341866, JIM341820, JIM341679, JIM341352, JIM343421, JIM341174, JIM336745, JIM340667, JIM338283, JIM-341592, JIM336957, JIM341996, JIM342334, JIM343694, JIM336855, JIM334236, JIM341415, JIM341392, JIM336481, JIM340934, JIM336167, JIM342249, JIM338290, JIM341750, JIM341426, JIM334986, JIM334527, JIM340024, JIM341021, JIM340658

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2143-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2143-2016	Class III	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-08

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)