# FDA recall Z-1540-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-01-30.

## Product

Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160    The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.

## Reason for recall

May produce erroneously low results from specific well sets.

## Distribution

Worldwide Distribution - USA (nationwide) and to the following countries:  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Italy,  Japan,  Norway,  Portugal,  Slovakia,  Slovenia,  South Korea,  Spain,  Switzerland

## Key facts

- **Recall number:** Z-1540-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-30
- **Report date:** 2018-05-09
- **Termination date:** 2019-05-16

- **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-1540-2018

## Citation

> AI Analytics. FDA recall Z-1540-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1540-2018. Source: US FDA. Licensed CC0.

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