Dimension Vista HDLC — Class II medical device recall Z-1188-2021
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2021-03-17, distributed nationwide. Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagen
| Recall number | Z-1188-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2021-02-03 |
| Classified | 2021-03-08 |
| Reported by FDA | 2021-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, DK, ES, FR, IT, NL, PT, SI, SK |
| Lot numbers | 20062BA |
Product
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
Reason for recall
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
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-1188-2021. 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.