Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-0553-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 17, 2021

Date Posted: February 9, 2022

Recall Number: Z-0553-2022

Event ID: 89244

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.

Status: Terminated

Product Quantity: 329

Code Information:

Lot Numbers AB3600A and AB3560A

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated