Siemens Dimension Vista — Class III medical device recall Z-0253-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2012-11-14, distributed nationwide. Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
| Recall number | Z-0253-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2012-08-03 |
| Classified | 2012-11-06 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2014-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 583 cartons |
| Reason classes | packaging |
| Lot numbers | 12062MA, 12066MA |
| Expiration dates | 2012-12-01, 2012-12-05 |
Product
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Reason for recall
Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
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-0253-2013. 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.