Device product
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Z-0491-2013
Product summary
- Event
- Event 63312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,015 units
- Official record key
device-enforcement:Z-0491-2013
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