Luminex Corporation: Medical Device Recall in 2022 - (Recall #: Z-0498-2022)

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, Part Number/REF 50-10017

Product Classification:

Class II

Date Initiated: April 16, 2021

Date Posted: January 26, 2022

Recall Number: Z-0498-2022

Event ID: 89303

Reason for Recall:

Impacted lot may leak inside the ARIES instrument.

Status: Terminated

Product Quantity: 296 kits

Code Information:

Lot number AB1703A

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated