# FDA recall Z-0553-2022

> **Luminex Corporation** · Class II · device recall initiated 2021-11-17.

## Product

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

## Reason for recall

Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.

## Key facts

- **Recall number:** Z-0553-2022
- **Recalling firm:** Luminex Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-17
- **Report date:** 2022-02-09
- **Termination date:** 2024-07-08

- **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-0553-2022

## Citation

> AI Analytics. FDA recall Z-0553-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0553-2022. Source: US FDA. Licensed CC0.

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