Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS… — Class II medical device recall Z-0541-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-12-25, distributed in CO, DC, IA, MD, NC, NJ, OH, VA…. Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
| Recall number | Z-0541-2014 |
|---|---|
| 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 | 2013-09-18 |
| Classified | 2013-12-19 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-10-01 |
| Distributed | CO, DC, IA, MD, NC, NJ, OH, VA, WI |
| Countries outside the US | AT, DK, FR, IT, NL, NO |
| Quantity | 302 |
| Lot numbers | 13064MA |
| Expiration dates | 2014-03-05 |
Product
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Reason for recall
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
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-0541-2014. 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.