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

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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 their ARIES SARS-CoV-2 Assay kits because a defect in the wash 1 syringe might cause false negative results. This means the test could incorrectly show a negative result when the person is actually infected.

Why it’s dangerous

A defect in the wash 1 syringe can cause incomplete extraction of the sample during the test process. This may lead to false negative results, where the test shows no infection when the person is actually infected.

Who’s affected

People who purchased the ARIES SARS-CoV-2 Assay kits with the listed lot numbers between May 2022 and June 2023 are affected. Those using the kits for home testing are most at risk of missing infections.

How to tell if you have this one

Check the lot number on the kit packaging, which is listed as AB4723A through AB6720A with expiration dates from May 2022 to June 2023.

Brand
Luminex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for the lot number on the kit packaging, which is listed as AB4723A through AB6720A with expiration dates from May 2022 to June 2023.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The recall is happening because a defect in the wash 1 syringe could lead to incomplete extraction, resulting in false negative test results.

What should I do if I have the recalled kit?

Check the lot number on the kit packaging to see if it matches the listed numbers. If it does, stop using it and contact Luminex for instructions.

Is there a risk of serious injury from this defect?

No, the hazard is limited to potential false negative results, which does not involve physical injury or health risks beyond inaccurate test results.

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-0134-2023 — Luminex Luminex

Hello,

I own a Luminex that is covered by recall Z-0134-2023 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-0134-2023 (September 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0134-2023 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, REF: 50-10047

Lower-risk recall