Recall Z-0430-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Dec 2, 2013 (initiated May 20, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | A notification letter was sent to consignees in May 2013. |
| Quantity | 776 |
| Distribution | Worldwide Distribution: USA (nationwide) and iinternationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |