# FDA recall Z-0331-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2021-10-15.

## Product

Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid  SMN: 10284473 (US) and 10488224 (OUS)

## Reason for recall

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT,  CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.

## Key facts

- **Recall number:** Z-0331-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-15
- **Report date:** 2021-12-08
- **Termination date:** 2024-05-13

- **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-0331-2022

## Citation

> AI Analytics. FDA recall Z-0331-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0331-2022. Source: US FDA. Licensed CC0.

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