PlainRecalls

Luminex Corporation

30 recalls on record · Latest: Jun 11, 2025

Luminex Corporation Recall Insight

Luminex Corporation appears on 30 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.036% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jun 11, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 30 entries, severity tagging shows 0 critical, 30 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 30 of 30 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (30). The date window on this page runs from Sep 5, 2018 to Jun 11, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 diagnosti…

FDA Devices Moderate Aug 14, 2024

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

FDA Devices Moderate Jul 5, 2023

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

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 Apr 20, 2022

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

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 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…

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…

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 d…

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 d…

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…

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 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 simulta…

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 ma…

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds