PlainRecalls

Luminex Corporation

Compiled from official public sources by the publisher.

39 recalls on record · Latest: Jun 11, 2025

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Agency notice ledger

Federal filing book Luminex Corporation MID-BOOK · SINGLE-AGENCY

#438 of 14,151 · 39 notices · 0.037% archive

  • BOOK 39 notices
  • RANK #438 of 14,151
  • SHARE 0.037% archive
  • AGENCY FDA Devices (39)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 11, 2025
  • PHOTO Brainlab Ag

Nearest notice-volume peer: Brainlab Ag (0 notice gap)

Luminex Corporation accounts for about 0.037% of the 104,423-notice archive on 39 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Luminex Corporation's standing among 14,151 recalling firms

Luminex Corporation ranks 438th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Luminex Corporation vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

39 438th of 14151 higher than 13,709 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Luminex Corporation in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Luminex Corporation holds about 0.037% of archive notices alongside 39 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 11, 2025

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
FDA Devices Moderate Aug 14, 2024

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
FDA Devices Moderate Dec 13, 2023

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.
FDA Devices Moderate Jul 5, 2023

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
FDA Devices Moderate Jul 5, 2023

Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
FDA Devices Moderate Nov 2, 2022

ARIES SARS-CoV-2 Assay, REF: 50-10047
FDA Devices Moderate Aug 24, 2022

ARIES SARS-CoV-2 Assay
FDA Devices Moderate Jul 13, 2022

VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
FDA Devices Moderate Jul 13, 2022

Verigene CDF Nucleic Acid Test, Part No. 30-002-22
FDA Devices Moderate May 25, 2022

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
FDA Devices Moderate May 25, 2022

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
FDA Devices Moderate Apr 20, 2022

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
FDA Devices Moderate Feb 9, 2022

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
FDA Devices Moderate Jan 26, 2022

ARIES HSV 1&2 Assay, Part Number/REF 50-10017
FDA Devices Moderate Sep 22, 2021

Verigene EP Amplification Reagent Kit Test
FDA Devices Moderate Jul 14, 2021

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
FDA Devices Moderate Jul 14, 2021

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
FDA Devices Moderate Jul 14, 2021

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
FDA Devices Moderate Jul 14, 2021

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
FDA Devices Moderate Jul 14, 2021

Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
FDA Devices Moderate Jul 14, 2021

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
FDA Devices Moderate May 5, 2021

VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
FDA Devices Moderate Dec 2, 2020

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 Verigene Test Cartridge for each sample tested.
FDA Devices Moderate Dec 2, 2020

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 Verigene Test Cartridge for each sample tested.
FDA Devices Moderate Oct 14, 2020

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
FDA Devices Moderate Aug 19, 2020

Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
FDA Devices Moderate Aug 19, 2020

Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
FDA Devices Moderate Aug 28, 2019

Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
FDA Devices Moderate Aug 21, 2019

ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
FDA Devices Moderate Aug 21, 2019

ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
FDA Devices Moderate Aug 21, 2019

ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
FDA Devices Moderate Aug 21, 2019

ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
FDA Devices Moderate Aug 21, 2019

ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
FDA Devices Moderate Aug 21, 2019

Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Devices Moderate Aug 21, 2019

ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Devices Low Feb 20, 2019

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture s
FDA Devices Moderate Nov 21, 2018

VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
FDA Devices Moderate Sep 5, 2018

Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
FDA Devices Moderate May 24, 2017

ARIES System and ARIES M1 System

Luminex Corporation holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Brainlab Ag 39 Cordis Corporation 39 K2M, Inc 39 Oscor Inc. 39

Frequently Asked Questions

How many federal recall notices name Luminex Corporation? ▼
PlainRecalls indexes 39 distinct federal recall events naming Luminex Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Luminex Corporation sit among other recalling firms? ▼
Luminex Corporation ranks #438 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Luminex Corporation's notices? ▼
FDA Devices accounts for 39 of this firm's 39 indexed notices.
What product category dominates Luminex Corporation's filing book? ▼
Filings for Luminex Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Luminex Corporation: 39 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Luminex Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026