Dimension Vista — Class II medical device recall Z-0430-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-12-11, distributed nationwide. There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incor
| Recall number | Z-0430-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-05-20 |
| Classified | 2013-12-02 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 776 |
| Reason classes | software |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0430-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.