Siemens Dimension Vista Magnesium Flex reagent cartridge — Class II medical device recall Z-0830-2022
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2022-04-06, distributed nationwide. Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay f
| Recall number | Z-0830-2022 |
|---|---|
| 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 | 2022-01-28 |
| Classified | 2022-03-28 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NL |
| Reason classes | potency |
| Lot numbers | 21253BB, 21263BA, 21335AA |
| Model numbers | K3057 |
Product
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).
Reason for recall
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.
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-0830-2022. 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.