Luminex ARIES SARS-CoV- 2 Assay Recall: False Negative Risk

Take action

Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Luminex is recalling its ARIES SARS-CoV-2 Assay (Lot AB4042A) because it might miss the ORF1ab gene, causing false negative results. This means the test could incorrectly show a negative result when the virus is actually present.

Why it’s dangerous

The test may not detect the ORF1ab gene, which is part of the SARS-CoV-2 virus. If both genes are missed, the test could show a negative result when the virus is actually present, leading to false negatives.

Who’s affected

People who purchased the ARIES SARS-CoV-2 Assay (Lot AB4042A) for home use. Those who rely on this test for accurate results are most at risk of missing infections.

How to tell if you have this one

Check the lot number on the test kit. The affected product is the ARIES SARS-CoV-2 Assay with lot number AB4042A.

Brand
Luminex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Test Lot Number
Look for the lot number AB4042A on the test kit.

✎ GovInfoNow

Questions people ask

Why is this test being recalled?

The test may not detect the ORF1ab gene, which can cause false negative results if both genes are missed.

What should I do if I have this test?

Check the lot number on the test kit. If it's AB4042A, contact Luminex for guidance.

Is this test dangerous?

No, this is a low-risk issue related to potential false negatives, not physical harm.

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-1524-2022 — Luminex Luminex

Hello,

I own a Luminex that is covered by recall Z-1524-2022 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-1524-2022 (July 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1524-2022 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 SARS-CoV-2 Assay

Lower-risk recall