FDA Enforcement
Class II
Terminated
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.
Recall: Z-0490-2013
·
Reported December 19, 2012
Enforcement
- Recall Number
- Z-0490-2013
- Event ID
- 63312
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Molecular Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 19, 2012
- Initiation Date
- July 16, 2012
- Classification Date
- December 7, 2012
- Termination Date
- July 22, 2015
- Address
- 1080 Us Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States
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.
Reason
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code Info
Device-associated diagnostic software
Distribution
Nationwide Distribution
Quantity
855 units.