FDA Device recall Z-0430-2014
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagn…
- FDA Device
- Class II
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class II recall of Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagn… by Siemens Healthcare Diagnostics, citing 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 Vis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0430-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-20 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
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
Identifiers
| code_info | Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0430-2014%22
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