# FDA recall Z-0499-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-10-11.

## Product

Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323

## Reason for recall

Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase  (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction  cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control  and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a  component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to  determine the etiology of tissue damage. Results would be correlated with clinical history and  presentation in addition to other diagnostic laboratory testing.

## Distribution

Worldwide-domestic nationwide and foreign distribution.

## Key facts

- **Recall number:** Z-0499-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-11
- **Report date:** 2018-12-05
- **Termination date:** 2020-06-29

- **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-0499-2019

## Citation

> AI Analytics. FDA recall Z-0499-2019. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0499-2019. Source: US FDA. Licensed CC0.

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