The Recall Desk

Manufacturer

Luminex Corporation

39 recalls in our database name Luminex Corporation as the manufacturing or recalling firm.

What the numbers show

Total
39
Critical
0
Severe
0
Most recent
2025-06-11

Of the 39 recalls from Luminex Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 39

  • HighFDA (Devices)·Z-1903-2025·2025-06-11

    Luminex VERIGENE Gram Negative Blood Culture Test Recalled

    Luminex is recalling VERIGENE Gram Negative Blood Culture test cartridges due to a consumable issue that may produce incorrect results on a small portion of one lot.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2533-2024·2024-08-14

    Verigene Gram Positive Blood Culture Test Recalled for Defective Cartridges

    Luminex recalls approximately 1,100 diagnostic kits due to defective test cartridges that may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium bacteria.

    Product
    Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0500-2024·2023-12-13

    Luminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects

    Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.

    Product
    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 20-012-018, containing 20 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2023·2023-07-05

    VERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results

    Luminex is recalling the VERIGENE C. difficile diagnostic test due to the possibility of false-negative results in rare instances caused by hydrophobic characteristics in specific FLOQSwab lots.

    Product
    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2023·2023-07-05

    Verigene nucleic acid test kits recalled for rare false-negative results

    Luminex Corporation recalls Verigene nucleic acid test kits that may rarely produce false-negative results due to hydrophobic properties in certain FLOQSwab lots. False-negative results could fail to detect enteric pathogens in patient samples.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2023·2022-11-02

    ARIES SARS-CoV-2 Assay Recalled Due to Syringe Defect

    Luminex is recalling certain lots of the ARIES SARS-CoV-2 Assay because a defect in the wash 1 syringe could cause incomplete sample extraction and produce false negative test results.

    Product
    ARIES SARS-CoV-2 Assay, REF: 50-10047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2022·2022-08-24

    ARIES SARS-CoV-2 Assay may produce false negative diagnostic results

    Luminex Corporation recalled 257 units of the ARIES SARS-CoV-2 Assay (lot AB4042A) due to potential false negative results. The assay may fail to detect the ORF1ab gene, risking missed COVID-19 infections.

    Product
    ARIES SARS-CoV-2 Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2022·2022-07-13

    Verigene CDF Nucleic Acid Test recalled for potential false negative results

    Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test due to potential false negative results caused by the swab's hydrophobic characteristics, which could result in missed positive diagnoses.

    Product
    Verigene CDF Nucleic Acid Test, Part No. 30-002-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2022·2022-07-13

    VERIGENE Enteric Pathogens Test may yield false negative results

    Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.

    Product
    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2022·2022-05-25

    Verigene Processor heating system may produce false negative results

    Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic results.

    Product
    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1109-2022·2022-05-25

    VERIGENE extraction tray reagent defect causes test control failures

    Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.

    Product
    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0920-2022·2022-04-20

    Verigene Processor SP Recalled for No Call Results

    Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.

    Product
    Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0553-2022·2022-02-09

    ARIES HSV 1&2 Diagnostic Cassettes May Leak, Affecting Test Results

    Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A) due to a confirmed 0.9% leak rate. Leaking cassettes may cause incorrect or delayed test results.

    Product
    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2022·2022-01-26

    Medical Device Assay Kits Recalled for Potential Instrument Leakage

    Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.

    Product
    ARIES HSV 1&2 Assay, Part Number/REF 50-10017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2021·2021-09-22

    FDA Recalls Luminex Verigene Enteric Pathogen Test Kits for False Positive Results

    Luminex Corporation is recalling 4,579 Verigene EP Amplification Reagent Kit Test units worldwide due to potential for false positive results. Affected kits distributed across the United States, Austria, France, Greece, Japan, and Turkey may produce incorrect test results.

    Product
    Verigene EP Amplification Reagent Kit Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2021·2021-07-14

    Verigene Gram Negative Blood Culture Test Recalled for Potential False-Negative Results

    Luminex Corporation is recalling 17,110 units of the Verigene Gram Negative Blood Culture test (Model 20-006-021) due to potential false-negative results that may fail to detect Gram-negative bacterial infections.

    Product
    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2021·2021-07-14

    Verigene Enteric Pathogens Test May Return False-Negative Results

    Luminex Corporation is recalling Verigene Enteric Pathogens diagnostic tests due to potential for false-negative results, which could miss serious bacterial infections.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2021·2021-07-14

    Luminex Verigene Respiratory Pathogens Test Recalled for False-Negative Risk

    Luminex Corporation is recalling 38,990 Verigene Respiratory Pathogens Flex nucleic acid tests due to potential false-negative results. The tests were distributed worldwide, including throughout the United States.

    Product
    Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2021·2021-07-14

    Verigene Gram Negative Blood Culture Test Recalled for Risk of False-Negative Results

    Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.

    Product
    Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2021·2021-07-14

    Verigene Gram-Positive Blood Culture Test Recalled for Potential False-Negative Results

    Luminex Corporation is recalling the Verigene BC-GP blood culture test (Model 20-006-018) due to the potential for false-negative results. Approximately 36,416 units have been distributed worldwide.

    Product
    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2021·2021-07-14

    Luminex Verigene C. difficile Test Kit Recalled for False-Negative Results

    Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.

    Product
    Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2021·2021-05-05

    Luminex VERIGENE Processor SP Recalled for Potential False-Negative Pathogen Results

    Luminex is recalling VERIGENE Processor SP units because they may produce false-negative results for specific enteric pathogens when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

    Product
    VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2021·2020-12-02

    Luminex Recalls Verigene Processor SP Due to Unapproved Test Fixtures

    Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.

    Product
    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0476-2021·2020-12-02

    Luminex Recalls Verigene Processor SP Due to Unapproved Service Fixtures

    Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate and verify the devices.

    Product
    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2021·2020-10-14

    Luminex VERIGENE Processor SP Recalled for Heater Failure

    Luminex is recalling one VERIGENE Processor SP system in Missouri due to a hybridization heater failure that may cause incorrect test results.

    Product
    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Luminex

biotech company based in Austin, Texas

Country
United States
Founded
1995
Parent company
DiaSorin

Official website

Source: Wikidata (Q6703279), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.