Devices

enGen Laboratory Automation System

Model / Serial
Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
Product Description
enGen Track System with TCAutomation Software Version 4.2
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of enGen Laboratory Automation System

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

36 devices with a similar name

Learn more about the data here

ortho-clinical diagnostics engen laboratory automation systemsortho clinical diagnostics - engen ...

Model / Serial
Product Description
ivd
Manufacturer
ORTHO CLINICAL DIAGNOSTICS

ortho clinical diagnostics engen laboratory automation systems

Model / Serial
Product Description
ivd
Manufacturer
DATA INNOVATIONS LNC

engen laboratory automation systems (engen)

Model / Serial
Product Description
ivd
Manufacturer
THERMO FISHER SCIENTIFIC OY CLINICAL DIAGNOSTICS FINLAND

engen laboratory automation systemsengen laboratory automation systems

Model / Serial
Product Description
ivd
Manufacturer
ORTHO CLINICAL DIAGNOSTICS

tcautomation / engen laboratory automation system - tca recapper ca 952238

Model / Serial
Product Description
ivd
Manufacturer
THERMO FISHER SCIENTIFIC OY CLINICAL DIAGNOSTICS FINLAND

31 more

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)