Z-1677-2014Class II

enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM)...

Name: Z-1677-2014 enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM)...
Creator: Ortho-Clinical Diagnostics
Published: 2014-03-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-03-20 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a... on 2014-03-20. FDA classified it as Class II and gives the reason as "Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the...". 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-1677-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-20
Posted: 2014-06-02
Terminated: 2017-04-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) 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 (TM) 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.
Root cause tag: software
FDA root cause: Software design
Action: US consignees were sent Urgent Product Correction Letters (Cl2014-102, dated 3/20/2014) on 3/20/2014 by FedEx or USPS (for PO Box addresses only) overnight mail, informing them of the issue and instructing them to ensure that all required data elements are entered and in the correct format when using the auto verification feature or custom rules. J&J Foreign affiliate consignees were notified by e-mail on 3/20/2014 informing them of the issue.
Quantity in commerce: Domestic: 20 units, Foreign: 61 units
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the 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: enGen (TM) Laboratory Automation Systems Configured with enGen (TM) Select or Custom (TM) v3.2.2 and below with Data Innovations, LLC Instrument Manager (TM) v8.06 with Data Innovations, LLC TCA Driver v8.04.0020 and below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1677-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1677-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

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)