--- title: "Luminex Corporation Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Luminex Corporation recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/luminex-corporation/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Luminex Corporation recall records **10** reported ongoing 12 records in this archive. Latest source date Apr 16, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 16, 2025 FDA device enforcement ### [VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test](https://isitonrecall.com/recall/fda-device-z-1903-2025-verigene-gram-negative-blood-culture-bc-gn-nucleic-acid-test-ref-20-006-021-for-use-with-the-sample/) It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges. Class II Reported completed Distribution: US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD. [Official source for VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1903-2025%22) Jun 20, 2024 FDA device enforcement ### [Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test](https://isitonrecall.com/recall/fda-device-z-2533-2024-verigene-gram-positive-blood-culture-bc-gp-nucleic-acid-test/) Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV. [Official source for Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2533-2024%22) Nov 7, 2023 FDA device enforcement ### [Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 2...](https://isitonrecall.com/recall/fda-device-z-0500-2024-luminex-verigene-bc-gp-utility-tray-5-pack-carrier-gram-positive-blood-culture-nucleic-acid-test-ref/) Potentially defective utility trays in the reagent kits. Class II Reported ongoing 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 It... [Official source for Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Te...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0500-2024%22) Jun 5, 2023 FDA device enforcement ### [Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023](https://isitonrecall.com/recall/fda-device-z-2023-2023-verigene-enteric-pathogens-nucleic-acid-test-ep-ref-30-002-023/) 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 spe... Class II Reported ongoing Distribution: Worldwide and US Nationwide Distribution [Official source for Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2023-2023%22) Jun 5, 2023 FDA device enforcement ### [VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022](https://isitonrecall.com/recall/fda-device-z-2024-2023-verigene-clostridium-difficile-nucleic-acid-test-ref-30-002-022/) 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 spe... Class II Reported ongoing Distribution: Worldwide and US Nationwide Distribution [Official source for VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2024-2023%22) Sep 14, 2022 FDA device enforcement ### [ARIES SARS-CoV-2 Assay, REF: 50-10047](https://isitonrecall.com/recall/fda-device-z-0134-2023-aries-sars-cov-2-assay-ref-50-10047/) A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. Class II Reported ongoing Distribution: Distribution US nationwide, Indonesia, and Hong Kong. [Official source for ARIES SARS-CoV-2 Assay, REF: 50-10047](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0134-2023%22) Jul 14, 2022 FDA device enforcement ### [ARIES SARS-CoV-2 Assay](https://isitonrecall.com/recall/fda-device-z-1524-2022-aries-sars-cov-2-assay/) SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA. [Official source for ARIES SARS-CoV-2 Assay](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1524-2022%22) Jun 17, 2022 FDA device enforcement ### [Verigene CDF Nucleic Acid Test, Part No. 30-002-22](https://isitonrecall.com/recall/fda-device-z-1334-2022-verigene-cdf-nucleic-acid-test-part-no-30-002-22/) There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey. [Official source for Verigene CDF Nucleic Acid Test, Part No. 30-002-22](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1334-2022%22) Jun 17, 2022 FDA device enforcement ### [VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23](https://isitonrecall.com/recall/fda-device-z-1335-2022-verigene-enteric-pathogens-nucleic-acid-test-part-no-30-002-23/) There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey. [Official source for VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1335-2022%22) Apr 5, 2022 FDA device enforcement ### [Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system](https://isitonrecall.com/recall/fda-device-z-1092-2022-verigene-processor-sp-models-10-0000-07-10-0000-07r-a-component-of-the-verigene-system/) Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results. Class II Reported ongoing Distribution: US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None [Official source for Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1092-2022%22) Feb 15, 2022 FDA device enforcement ### [VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021](https://isitonrecall.com/recall/fda-device-z-1109-2022-verigene-nucleic-acid-test-kit-bc-gn-extraction-tray-9-73-ml-ref-20-009-021/) Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot. Class II Reported ongoing Distribution: US [Official source for VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1109-2022%22) Nov 17, 2021 FDA device enforcement ### [ARIES HSV 1&2 Assay, Catalog/REF# 50-10017](https://isitonrecall.com/recall/fda-device-z-0553-2022-aries-hsv-1-2-assay-catalog-ref-50-10017/) Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid. Class II Reported terminated Distribution: Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, W... [Official source for ARIES HSV 1&2 Assay, Catalog/REF# 50-10017](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0553-2022%22) ## Reasons in these listed records - It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges. - Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. - Potentially defective utility trays in the reagent kits. - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Luminex Corporation ### Is there a recall on luminex corporation right now? This archive contains 12 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Luminex Corporation](https://isitonrecall.com/check/?q=Luminex%20Corporation) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)