Z-1724-2015Class II

enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following...

Name: Z-1724-2015 enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following...
Creator: Ortho-Clinical Diagnostics
Published: 2015-05-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-05-06 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes... on 2015-05-06. FDA classified it as Class II and gives the reason as "Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1724-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Posted: 2015-06-08
Terminated: 2018-05-25
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073). COMMON NAME: enGen Track System. 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit module. These situations may result in splashing of bio-hazardous fluid. Sample cross-contamination may occur with an uncapped tube in the rack.
FDA root cause: Component change control
Action: On 5/06/2015, a customer letter (Ref. CL2015-092) with recommendation to prevent this issue was sent to all customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by email to subscribers of ORTHO PLUS e-Communications. Foreign affiliate consignees were notified by e-mail on 5/06/2015 informing them of the issue. For questions, please call Customer Technical Services at 1-800-421-3311 at any time.
Quantity in commerce: 45 units worldwide (Domestic: 19 units, Foreign: 26)
Distribution: Worldwide distribution. US Nationwide, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.
Product codes and lots: Serial Numbers: J89134, JIM341226, 341516, JIM342964, JIM340432, JIM340814, IM341243, JIM336912, J271265, J271369, J271372, J271267, J85208, JIM342217, J7023890, J7023841, J7025007, J7024894, J7023648, J7021530, J57662, J8006290, J75685, J30370, J3055510, J3055507, JIM341820, JIM341679, JIM341174, JIM340667, JIM-341592, JIM336957, JIM341477, JIM336855, JIM334236, JIM341415, JIM341392, JIM340934, JIM336167, JIM342249, JIM341750, JIM341426, JIM334527, JIM341021, JIM340658.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1724-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1724-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

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)