Magnesium Flex reagent cartridge — Class II medical device recall Z-0767-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2025-01-01, distributed nationwide. Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reage
| Recall number | Z-0767-2025 |
|---|---|
| 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 | 2024-11-12 |
| Classified | 2024-12-26 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, DE, DK, ES, FR, IT, SI |
| UPC / GTIN / UDI-DI | 00842768015694 |
| Lot numbers | 24057BB, 24064BC |
| Model numbers | K3057 |
Product
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Reason for recall
Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out
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-0767-2025. 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.