Device product
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.
Z-0490-2013
Product summary
- Event
- Event 63312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 855 units.
- Official record key
device-enforcement:Z-0490-2013
Official wording
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information: Device-associated diagnostic software
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Device software or design
software issue