# FDA recall Z-0498-2022

> **Luminex Corporation** · Class II · device recall initiated 2021-04-16.

## Product

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

## Reason for recall

Impacted lot may leak inside the ARIES instrument.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.

## Key facts

- **Recall number:** Z-0498-2022
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-16
- **Report date:** 2022-01-26
- **Termination date:** 2024-09-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2022

## Citation

> AI Analytics. FDA recall Z-0498-2022. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0498-2022. Source: US FDA. Licensed CC0.

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