# FDA recall Z-0830-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-01-28.

## 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.

## Distribution

Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, AZ, CA,  CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY) and OUS countries of: Australia, Canada and Netherlands.

## Key facts

- **Recall number:** Z-0830-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-28
- **Report date:** 2022-04-06

- **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-0830-2022

## Citation

> AI Analytics. FDA recall Z-0830-2022. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0830-2022. Source: US FDA. Licensed CC0.

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