Devices

Device Recall cobas Integra 400/400 Plus

Model / Serial
Device-associated diagnostic software
Product Classification
General Hospital and Personal Use Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Manufacturer
Roche Molecular Systems, Inc.
1 Event
- Recall of Device Recall cobas Integra 400/400 Plus

Manufacturer

Roche Molecular Systems, Inc.

Manufacturer Address
Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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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.

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