Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500… — Class II medical device recall Z-0838-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-12-31. Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance
| Recall number | Z-0838-2015 |
|---|---|
| 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 | 2014-11-05 |
| Classified | 2014-12-20 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2017-10-06 |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, KR, MY, NL, NO, NZ, PT, SA, SI, SK, ZA |
| Quantity | 1,949 |
Product
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Reason for recall
Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.
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-0838-2015. 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.