Luminex Corporation

Complete recall history across all FDA and CPSC categories — 39 total recalls

Luminex Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (39)

FDA medical device enforcement actions by Luminex Corporation

Date Product Reason Class
Apr 16, 2025 VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-02... It was determined that the consumable issue may result in No Call - INT CTL 1... Class II
Jun 20, 2024 Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Potential for defective test cartridges which may result in false positive re... Class II
Nov 7, 2023 Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cul... Potentially defective utility trays in the reagent kits. Class II
Jun 5, 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 ... Class II
Jun 5, 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 ... Class II
Sep 14, 2022 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 in... Class II
Jul 14, 2022 ARIES SARS-CoV-2 Assay SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect th... Class II
Jun 17, 2022 Verigene CDF Nucleic Acid Test, Part No. 30-002-22 There is a potential for false negative results using VERIGENE CDF Stool PREP... Class II
Jun 17, 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... Class II
Apr 5, 2022 Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Veri... Heater within the Verigene System may be outside of established temperature ... Class II
Feb 15, 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 reage... Class II
Nov 17, 2021 ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak r... Class II
Aug 3, 2021 Verigene EP Amplification Reagent Kit Test There is potential for false positive results. Class II
Apr 16, 2021 ARIES HSV 1&2 Assay, Part Number/REF 50-10017 Impacted lot may leak inside the ARIES instrument. Class II
Mar 18, 2021 VERIGENE Processor SP - Product Usage: intended for processing and identifyin... Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella... Class II
Oct 30, 2020 Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: ... Potential for a false-negative result. Class II
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Num... Potential for a false-negative result. Class II
Oct 30, 2020 Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-0... Potential for a false-negative result. Class II
Oct 30, 2020 Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 Potential for a false-negative result. Class II
Oct 30, 2020 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: ... Potential for a false-negative result. Class II
Oct 30, 2020 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number:... Potential for a false-negative result. Class II
Oct 13, 2020 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... Luminex has determined that three (3) separate test fixtures used by field se... Class II
Oct 13, 2020 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with a... Luminex has determined that three (3) separate test fixtures used by field se... Class II
Jun 15, 2020 Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Cultu... An instrument failure mode that may result in a Blood Culture Gram Positive (... Class II
Jun 15, 2020 Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Cultur... An instrument failure mode that may result in a Blood Culture Gram Positive (... Class II
Apr 22, 2019 Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R Two of three complaints were initiated due to the customers repeatedly obtain... Class II
Feb 20, 2019 ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073 Through internal investigation, it was discovered that a portion of side ca... Class II
Feb 20, 2019 Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 Through internal investigation, it was discovered that a portion of side ca... Class II
Feb 20, 2019 ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 Through internal investigation, it was discovered that a portion of side ca... Class II
Feb 20, 2019 ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 Through internal investigation, it was discovered that a portion of side ca... Class II
Feb 20, 2019 ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 Through internal investigation, it was discovered that a portion of side ca... Class II
Feb 20, 2019 ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 Through internal investigation, it was discovered that a portion of side ca... Class II
Feb 20, 2019 ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 Through internal investigation, it was discovered that a portion of side ca... Class II
Dec 26, 2018 Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G... On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the V... Class III
Dec 10, 2018 VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device i... No results/incorrect results due to failure of the hybridization heater. Class II
Sep 14, 2018 VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac... Potential to lead to a false negative results. Class II
Jun 29, 2018 Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... An incorrect control board and firmware installed in some of the Hand Held Ba... Class II
May 8, 2018 Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... Elevated false positive results Yersinia enterocolitica (Yersinia) from custo... Class II
Apr 19, 2017 ARIES System and ARIES M1 System The hand-held barcode scanner that is used as an accessory to enter ARIES cas... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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