Device product
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
Z-0430-2014
Product summary
- Event
- Event 65408
- Status
- Terminated
- Classification
- Class II
- Quantity
- 776
- Official record key
device-enforcement:Z-0430-2014
Official wording
Reason: There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1
Code information: Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801
Distribution pattern: Worldwide Distribution: USA (nationwide) and iinternationally to Canada.
Derived failure modes
-
Unknown
There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1