Luminex Verigene BC-GN Blood Test Recall: False Negative Risk

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Recalling firmLuminex Corporation4088 Commercial Ave · Northbrook, IL 60062-1829

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Luminex is recalling Verigene Gram Negative Blood Culture Nucleic Acid Test (Model 20-006-021) because it can give false negative results, meaning infections might not be detected properly. This could lead to missed diagnoses and delayed treatment.

Why it’s dangerous

The test may produce false negative results, meaning it could fail to detect certain bacterial infections in blood samples. This could lead to incorrect conclusions about infection presence and potentially delay appropriate treatment.

Who’s affected

Healthcare professionals using the Verigene Gram Negative Blood Culture Nucleic Acid Test for blood culture analysis are affected. Patients relying on this test for infection detection may be at risk of undiagnosed infections.

How to tell if you have this one

Check for the model numbers listed: 20-006-021, 030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A.

Brand
Luminex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Verify if your test kit has any of the listed model numbers: 20-006-021, 030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, or 082620021A.

✎ GovInfoNow

Questions people ask

Why is this test being recalled?

The test may produce false negative results, meaning it could fail to detect certain bacterial infections in blood samples.

What should I do if I have this test?

Check the model numbers on your test kit. If it matches the listed models, contact Luminex for instructions.

Is there a risk of serious injury?

No, the hazard is limited to potential false negative results, which does not cause physical injury but could lead to missed diagnoses.

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-2008-2021 — Luminex Luminex

Hello,

I own a Luminex that is covered by recall Z-2008-2021 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-2008-2021 (October 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2008-2021 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 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

Lower-risk recall