Luminex ARIES HSV 1&2 Assay Recall: Leaking Cassettes May Cause Incorrect Results

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Recalling firmLuminex Corporation12212 Technology Blvd, N/A · Austin, TX 78727-6101

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Luminex is recalling specific lots of ARIES HSV 1&2 Assay kits because they may leak, which could lead to incorrect test results or delayed reporting. This affects laboratory users who rely on these kits for testing.

Why it’s dangerous

The recalled lots have a 0.9% leak rate, which means some cassettes may leak inside the instrument. Leaking cassettes can cause incorrect test results or delay reporting because the system may flag the test as invalid.

Who’s affected

Laboratory users who purchased the ARIES HSV 1&2 Assay kits with lot numbers AB3600A or AB3560A are affected. Those using these kits for diagnostic testing are most at risk of incorrect results.

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.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

Testing confirmed a leak rate of 0.9% in the affected lots, which could lead to incorrect test results or delayed reporting due to invalid results.

How can I tell if my kit is affected?

The affected kits have lot numbers AB3600A or AB3560A and catalog/ref number 50-10017.

What should I do if I have the affected kit?

The recall record does not specify a remedy, so contact Luminex Corporation for guidance.

Take action

Contact Luminex

We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0553-2022 — Luminex Luminex

Hello,

I own a Luminex that is covered by recall Z-0553-2022 from Luminex.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-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.

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

Lower-risk recall