Dimension Vista 500- In-vitro diagnostic device intended to duplicate… — Class II medical device recall Z-0331-2022
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2021-12-08, distributed nationwide. Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
| Recall number | Z-0331-2022 |
|---|---|
| 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 | 2021-10-15 |
| Classified | 2021-12-02 |
| Reported by FDA | 2021-12-08 |
| Terminated | 2024-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,326 units |
| UPC / GTIN / UDI-DI | 00630414949581, 00630414989556 |
Product
Dimension Vista 500- 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 fluid SMN: 10284473 (US) and 10488224 (OUS)
Reason for recall
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
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-0331-2022. 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.