Lower risk Medical device recall · FDA · Published November 7, 2023

Luminex VERIGENE BC-GP Utility Tray Recall: Defective Trays Risk Test Errors

Luminex recalls 5-pack utility trays for Gram-Positive Blood Culture tests due to potential defects causing test errors. Affected units include specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #Z-0500-2024Medical device Luminex ›

Lower-risk recall

Potentially defective utility trays in the reagent kits.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Luminex is recalling 5-pack utility trays for Gram-Positive Blood Culture Nucleic Acid Tests because they may have defects that cause inaccurate test results. This affects labs using the specific lot numbers and expiration dates listed in the recall. Read more at govinfonow.com/recall/56928-luminex-verigene-bc-gp-utility-tray-recall-defective-trays-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56928-luminex-verigene-bc-gp-utility-tray-recall-defective-trays-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0500-2024

Cite this page

“Luminex VERIGENE BC-GP Utility Tray Recall: Defective Trays Risk Test Errors.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56928-luminex-verigene-bc-gp-utility-tray-recall-defective-trays-risk. Based on FDA recall #Z-0500-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0500-2024%22&limit=1).

Luminex Corporation voluntarily recalled Luminex VERIGENE BC-GP Utility Trays due to potentially defective utility trays in reagent kits, according to the FDA on November 7, 2023.

How to tell if you have it

Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018
UPC 00840487101674
Lot number 062123018C

The hazard

The recall involves potentially defective utility trays in the reagent kits.

Context

GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Other recent recalls of similar products include Luminex VERIGENE Gram Negative Blood Culture Test Recall (April 16, 2025), Luminex Verigene Gram Positive Blood Culture Test Recall (June 20, 2024), and Luminex Verigene Enteric Pathogens Test Kit Recall (June 5, 2023). Other recent recalls of similar products include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).

How to tell if you have this one

Check if your Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier) has lot number 062123018C and expires by 12/20/2023. The product is part of the Luminex VERIGENE BC-GP Utility Kit (REF 20-012-018) containing 20 tests.

Brand
Luminex
Product
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your utility tray's lot number and expiration date to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 24 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Delaware, Florida, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 36 days after the firm started it.

Nov 7, 2023Firm started the recall
Dec 6, 2023FDA classified it Class II
Dec 13, 2023Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Luminex recalls

Link to this recall

<a href="https://govinfonow.com/recall/56928-luminex-verigene-bc-gp-utility-tray-recall-defective-trays-risk">Luminex VERIGENE BC-GP Utility Tray Recall: Defective Trays Risk Test Errors (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-0500-2024 (November 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0500-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.