Dimension Vista System — Class II medical device recall Z-0339-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-12-02, distributed nationwide. Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain
| Recall number | Z-0339-2016 |
|---|---|
| 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 | 2015-09-30 |
| Classified | 2015-11-25 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,601 |
| Lot numbers | 15063BA |
| Model numbers | 10445158, K3057 |
Product
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
Reason for recall
Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%.
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-0339-2016. 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.