# FDA recall Z-0767-2025

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2024-11-12.

## 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

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.

## Key facts

- **Recall number:** Z-0767-2025
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-12
- **Report date:** 2025-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2025

## Citation

> AI Analytics. FDA recall Z-0767-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0767-2025. Source: US FDA. Licensed CC0.

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