Z-0553-2022Class II

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

Name: Z-0553-2022 ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Creator: Luminex Corporation
Published: 2021-11-17
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2021-11-17 / Terminated / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 on 2021-11-17. FDA classified it as Class II and gives the reason as "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". 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-0553-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-17
Posted: 2022-02-02
Terminated: 2024-07-08
Recalling firm: Luminex Corporation
Product: ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Product code: OOI Real Time Nucleic Acid Amplification System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 11/17/2021, the firm notified affected customers via letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated, if you observe any leaks, please contact Luminex Global Support Services at [email protected]. Please inform all those who need to be aware within your organization of this potential product performance issue. Please contact Luminex Global Support Services at [email protected] at your earliest convenience if you have a Kit with an affected lot to arrange for its replacement, and to confirm the disposal of any remaining Kits in your inventory. We ask that you complete and return the attached acknowledgement letter so that we can confirm the destruction of recalled lots. Luminex Global Support Services, 1-877-785-2323 (U.S. and Canada}, +1-512-381-4397 (Outside U.S. and Canada), [email protected]
Quantity in commerce: 329
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.
Product codes and lots: Lot Numbers AB3600A and AB3560A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0553-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0553-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-02-02

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)