Z-0498-2022Class II

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

Name: Z-0498-2022 ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Creator: Luminex Corporation
Published: 2021-04-16
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2021-04-16 / Terminated / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of ARIES HSV 1&2 Assay, Part Number/REF 50-10017 on 2021-04-16. FDA classified it as Class II and gives the reason as "Impacted lot may leak inside the ARIES instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0498-2022
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Posted: 2022-01-14
Terminated: 2024-09-20
Recalling firm: Luminex Corporation
Product: ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: Impacted lot may leak inside the ARIES instrument.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On 04/16/2021, the firm notified affected customers via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated the following: " Please inform all those who need to be aware within your organization of this potential product performance issue. At this time, you should destroy any inventory of these ARIES HSV 1&2 Assays. Please follow the "Steps in Voluntary Recall" directions found on the following pages of this notification. The Acknowledgment and Receipt Form must be completed and returned, even if you do not have any remaining product, by April 26th, 2021. We appreciate your assistance with this matter. Please call Luminex's Global Support Services if you have any questions or concerns. Luminex Global Support Services 1-877-785-2323 (U .S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) [email protected] CAN-0282, Rev A
Quantity in commerce: 296 kits
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.
Product codes and lots: Lot number AB1703A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0498-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0498-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-26	2022-01-14

Product code OOI

K161495Class IIARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)Luminex Corporation / cleared 2016-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)