FDA Device recall Z-0253-2013
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of t…
- FDA Device
- Class III
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class III recall of Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of t… by Siemens Healthcare Diagnostics, citing cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0253-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-03 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
Identifiers
| code_info | Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0253-2013%22
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