Lower risk Medical device recall · FDA · Published June 5, 2023

Luminex VERIGENE C. diff Test Kits May Give False Negatives - Recall

Luminex recalls specific VERIGENE C. diff test kits that may give false negative results due to hydrophobic characteristics in certain FLOQSwab lots. Affected kits have lot numbers 071222022D and 100622022D.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2024-2023Medical device Luminex ›

Lower-risk recall

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Luminex is recalling two specific VERIGENE Clostridium difficile Nucleic Acid Test kits that could give false negative results in rare cases. This means the test might incorrectly show no infection when it's actually present, which could lead to missing a serious health issue. Read more at govinfonow.com/recall/57902-luminex-verigene-c-diff-test-kits-may-give-false-negatives.

Source Summary by GovInfoNow · govinfonow.com/recall/57902-luminex-verigene-c-diff-test-kits-may-give-false-negatives · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2024-2023

Cite this page

“Luminex VERIGENE C. diff Test Kits May Give False Negatives - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57902-luminex-verigene-c-diff-test-kits-may-give-false-negatives. Based on FDA recall #Z-2024-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2024-2023%22&limit=1).

The FDA announced on June 5, 2023, that Luminex Corporation is recalling the VERIGENE Clostridium difficile Nucleic Acid Test due to potential false-negative results. The agency issued recall number Z-2024-2023 for the device.

How to tell if you have it

Brand: Luminex
Product: VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Lot Numbers: 071222022D, 100622022D

The hazard

The VERIGENE CDF Nucleic Acid Test Kit and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit could provide a false-negative result. This issue stems from hydrophobic characteristics in specific FLOQSwab lots.

Context

GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Other recent recalls of similar products include the Luminex VERIGENE Gram Negative Blood Culture Test Recall (April 16, 2025) and the Luminex Verigene Gram Positive Blood Culture Test Recall (June 20, 2024). Additional comparable recalls involve the Meridian Bioscience Revogene C. difficile Test (December 5, 2025), the Biomerieux VITEK 2 AST-N461 Test Kit (July 24, 2026), and the LH One Step Ovulation Test Device (November 22, 2025).

How to tell if you have this one

Check the lot number on the test kit packaging. Affected kits have lot numbers 071222022D or 100622022D. The product is sold under the VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022.

Brand
Luminex
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide and US Nationwide Distribution

Recall number	Product, codes & lots	Quantity
Z-2023-2023	Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023; UDI/DI 00840487101568, Lot Numbers: 071322023D, 071822023B, 071822023C, 071922023E, 072022023D, 072622023D, 082422023G, 083022023E, 083122023E, 090622023A, 090822023D, 091322023D, 091422023D, 091422023E, 092022023E, 092122023D, 092722023D, 092822023D, 100422023D, 100722023E, 101422023E, 101822023D, 101822023E, 101922023D, 102022023D, 121322023D, 122722023C, 122722023D, 010323023D, 011323023G, 021323023A, 021323023B, 021523023D, 022123023E, 022323023D, 030123023F, 030223023D, 030223023E, 030623023A, 030823023D, 031623023D	3987 units
Z-2024-2023	VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022; UDI/DI , Lot Numbers: 071222022D, 100622022D	114 units

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for lot numbers 071222022D or 100622022D on the test kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide and US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 30 days after the firm started it.

Jun 5, 2023Firm started the recall
Jun 28, 2023FDA classified it Class II
Jul 5, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these test kits?

No, but you should check the lot number to ensure you have an unaffected kit.

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Link to this recall

<a href="https://govinfonow.com/recall/57902-luminex-verigene-c-diff-test-kits-may-give-false-negatives">Luminex VERIGENE C. diff Test Kits May Give False Negatives - Recall (GovInfoNow)</a>

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-2024-2023 (June 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2024-2023 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.