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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