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.
“Luminex ARIES HSV 1&2 Assay Recall: Leaking Cassettes May Cause Incorrect Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61530-luminex-aries-hsv-1-2-assay-recall-leaking-cassettes-may. Based on FDA recall #Z-0553-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0553-2022%22&limit=1).
The FDA announced on November 17, 2021, that Luminex Corporation is recalling the ARIES HSV 1&2 Assay due to potential leaking cassettes. The agency issued recall number Z-0553-2022 for the Class II device.
How to tell if you have it
Brand: Luminex
Product: ARIES HSV 1&2 Assay
Catalog/REF#: 50-10017
Lot Numbers: AB3600A and AB3560A
The hazard
The FDA stated that impacted lots may leak inside the ARIES instrument, with testing confirming a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid error.
Context
GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Other recent recalls of similar products include the Luminex VERIGENE Gram Negative Blood Culture Test Recall (April 16, 2025), the Luminex Verigene Gram Positive Blood Culture Test Recall (June 20, 2024), and the Luminex VERIGENE BC-GP Utility Tray Recall (November 7, 2023). Other recent recalls of similar products include the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and the Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026).
How to tell if you have this one
Check the lot number on the ARIES HSV 1&2 Assay kit. The affected lots are AB3600A and AB3560A. These kits were sold with catalog/ref number 50-10017.
Brand
Luminex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Identify the lot number on the ARIES HSV 1&2 Assay kit to see if it is AB3600A or AB3560A.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0553-2022 (November 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0553-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.