Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ARIES HSV 1&2 Assay Recalled by Luminex Corporation Due to Impacted lot may leak inside the ARIES instrument....

Date: November 17, 2021
Company: Luminex Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Luminex Corporation directly.

Affected Products

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

Quantity: 329

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Luminex Corporation

Luminex Corporation has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report