Luminex ARIES HSV 1&2 Assay Recall: Leaking Instrument Risk
Luminex recalls ARIES HSV 1&2 Assay (part 50-10017) due to potential internal leaks. Affected units sold with lot AB1703A. Stop using if leaking.
Lower-risk recall
Impacted lot may leak inside the ARIES instrument.
Contact the company
What happened, in plain English
Luminex is recalling its ARIES HSV 1&2 Assay (part number 50-1:10017) because some units may leak internally. This could cause contamination or damage to the instrument if not addressed. Read more at govinfonow.com/recall/62776-luminex-aries-hsv-1-2-assay-recall-leaking-instrument-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62776-luminex-aries-hsv-1-2-assay-recall-leaking-instrument-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0498-2022
Cite this page
“Luminex ARIES HSV 1&2 Assay Recall: Leaking Instrument Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62776-luminex-aries-hsv-1-2-assay-recall-leaking-instrument-risk. Based on FDA recall #Z-0498-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0498-2022%22&limit=1).
Why it’s dangerous
The assay may leak internally, potentially causing contamination or damage to the instrument. This could lead to inaccurate test results or instrument malfunction if not addressed.
Who’s affected
Users of the ARIES HSV 1&2 Assay with lot number AB1703A are affected. Laboratory staff and researchers using this assay are most at risk.
How to tell if you have this one
Check for the part number 50-10017 on the ARIES HSV 1&2 Assay. Affected units were sold with lot number AB1703A.
- Brand
Luminex- Category
Medical device
What to do — step by step
Check for Leaks
Inspect the assay for signs of internal leakage, such as unusual fluid buildup or odors.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 23 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall affecting my lab equipment?
The recall applies only to the specific assay (part 50-10017) with lot AB1703A, not all lab equipment.
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Where this comes from
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-0498-2022 (April 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0498-2022 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.