Luminex Corporation
39 recalls on record · Latest: Jun 11, 2025
Luminex Corporation Recall Insight
Luminex Corporation appears on 39 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.038% 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 39 entries, severity tagging shows 0 critical, 38 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 39 of 39 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 (39). The date window on this page runs from May 24, 2017 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.
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…
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
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 VERIG…
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
ARIES SARS-CoV-2 Assay, REF: 50-10047
ARIES SARS-CoV-2 Assay
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Verigene EP Amplification Reagent Kit Test
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
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…
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…
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use d…
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use d…
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling…
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
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…
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simulta…
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence ma…
ARIES System and ARIES M1 System
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Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.