Device product
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Z-0489-2013
Product summary
- Event
- Event 63312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77 units
- Official record key
device-enforcement:Z-0489-2013
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