Luminex Corporation recalls
Every recall we track for Luminex Corporation — 38 in all, from 2018–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Luminex Corporation peaked in 2020 (10); 38 since 2017.
All FDA recall records for Luminex Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 5 | 0 | 5 |
| 2019 | 0 | 0 | 8 | 0 | 8 |
| 2020 | 0 | 0 | 10 | 0 | 10 |
| 2021 | 0 | 0 | 4 | 0 | 4 |
| 2022 | 0 | 0 | 6 | 0 | 6 |
| 2023 | 0 | 0 | 3 | 0 | 3 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Luminex Corporation recalls
What to do if you have a recalled Luminex Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Luminex Corporation recalls
23 shown- Lower riskMedical device
Luminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results
Luminex recalls VERIGENE Gram Negative Blood Culture test cartridges due to potential false negatives in small portions of the lot. Affected units have specific lot numbers and expiration dates.
LuminexApr 16, 2025 - Lower riskMedical device
Luminex Corporation recalls Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Luminex recalls Verigene Gram Positive Blood Culture test cartridges that may cause false positives for Staphylococcus lugdunensis and Enterococcus faecium. Affected units have specific lot numbers and expiration dates.
LuminexJun 20, 2024 - Lower riskMedical device
Luminex Corporation recalls Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a
Luminex recalls 5-pack utility trays for Gram-Positive Blood Culture tests due to potential defects causing test errors. Affected units include specific lot numbers and expiration dates.
LuminexNov 7, 2023 - Lower riskMedical device
Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Luminex recalls specific VERIGENE C. diff test kits that may give false negative results due to hydrophobic characteristics in certain FLOQSwab lots. Affected kits have lot numbers 071222022D and 100622022D.
LuminexJun 5, 2023 - Lower riskMedical device
Luminex Corporation recalls ARIES SARS-CoV-2 Assay, REF: 50-10047
Luminex recalls ARIES SARS-CoV-2 Assay kits with specific lot numbers due to potential false negative results from a wash 1 syringe defect.
LuminexSep 14, 2022 - Lower riskMedical device
Luminex Corporation recalls ARIES SARS-CoV-2 Assay
Luminex recalls ARIES SARS-CoV-2 Assay (Lot AB4042A) due to potential false negatives from missed ORF1ab gene detection. Consumers should verify test results with a different test.
LuminexJul 14, 2022 - Lower riskMedical device
Luminex Corporation recalls VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Luminex recalls specific VERIGENE Enteric Pathogens Nucleic Acid Test kits that may produce false negative results due to swab hydrophobic characteristics. Affected kits include certain Luminex and FLOQSwab lot numbers.
LuminexJun 17, 2022 - Lower riskMedical device
Luminex Corporation recalls Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Luminex recalls Verigene Processor SP models 10-0000-07/10-0000-07R due to potential false negative results from temperature issues in the Verigene system.
LuminexApr 5, 2022 - Lower riskMedical device
Luminex Corporation recalls VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Luminex recalls specific VERIGENE Nucleic Acid Test Kit extraction trays due to potential no call internal control failures from missing reagents. Affected units include lot 101321021B.
LuminexFeb 15, 2022 - Lower riskMedical device
Luminex Corporation recalls ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Luminex recalls ARIES HSV 1&2 Assay (lot AB3600A, AB356: 0.9% leak rate may cause incorrect test results or delayed reporting due to invalid results.
LuminexNov 17, 2021 - Lower riskMedical device
Luminex Corporation recalls Verigene EP Amplification Reagent Kit Test
Luminex recalls Verigene EP Amplification Reagent Kit Test with potential for false positive results. Affected lots include specific model numbers and dates. Consumers should check their kit's lot number and contact Luminex for details.
LuminexAug 3, 2021 - Lower riskMedical device
Luminex Corporation recalls ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Luminex recalls ARIES HSV 1&2 Assay (part 50-10017) due to potential internal leaks. Affected units sold with lot AB1703A. Stop using if leaking.
LuminexApr 16, 2021 - Lower riskMedical device
Luminex Corporation recalls VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold
Luminex Corporation recalls VERIGENE Processor SP devices with specific serial numbers due to potential false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella. Affected units may not detect these pathogens correctly when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
LuminexMar 18, 2021 - Lower riskMedical device
Luminex Corporation recalls Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Luminex recalls Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model 20-006-024 due to potential false-negative results. Consumers should check product codes for affected units.
LuminexOct 30, 2020 - Lower riskMedical device
Luminex Corporation recalls Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood
Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07R used with Gram-Positive Blood tests due to unapproved test fixtures causing calibration errors. Affected units have specific serial numbers listed in the recall.
LuminexOct 13, 2020 - Lower riskMedical device
Luminex Corporation recalls Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product
Luminex recalls Verigene Processor SP devices with specific serial numbers that may produce false negative results for Gram-Negative Blood Culture tests, potentially leading to missed infections. Affected units include those with serial numbers listed in the recall.
LuminexJun 15, 2020 - Lower riskMedical device
Luminex Corporation recalls Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07-R due to repeated No Call results. Affected units have specific serial numbers listed in the recall notice.
LuminexApr 22, 2019 - Lower riskMedical device
Luminex Corporation recalls ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Luminex recalls ARIES HSV 1&2 Assay (REF 50-10017) due to potential partial sealing of side cassette assemblies, which may decrease solution volume and assay sensitivity. Affected units include specific lot numbers with discontinuation dates.
LuminexFeb 20, 2019 - Lower riskMedical device
Luminex Corporation recalls Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test
Luminex recalls Vergene Amplification Tray (700uL, BC-GP REF 20-011-018) due to labeling error on Verigene Gram-Positive Blood Culture Nucleic Acid Test kits. Affected units have specific UDI and lot numbers.
LuminexDec 26, 2018 - Lower riskMedical device
Luminex Corporation recalls VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying
Luminex recalls VERIGENE Processor SP Model 10-0000-07 due to potential incorrect test results from hybridization heater failure. Affected units may need repair or replacement.
LuminexDec 10, 2018 - Lower riskMedical device
Luminex Corporation recalls VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro
Luminex recalls VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (five-pack carriers) due to potential false negative results in bacterial detection tests. Affected units include specific supplier and utility tray lots.
LuminexSep 14, 2018 - Lower riskMedical device
Luminex Corporation recalls Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories.
Luminex recalls Aries M1 System software v1.0 for in vitro diagnostics due to potential patient sample mismatches and duplicate results. Affected units have specific scanner labels and were sold after April 2017.
LuminexJun 29, 2018 - Lower riskMedical device
Luminex Corporation recalls Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria,
Luminex recalls Verigene Enteric Pathogens Nucleic Acid Test kits with specific cartridge model due to risk of false Yersinia enterocolitica results. Affected units include lot 032718023A.
LuminexMay 8, 2018
Luminex Corporation recall questions
How many recalls has Luminex Corporation had?
38 recalls from Luminex Corporation are on record with U.S. safety agencies, from 2018–2025.
What is the most recent Luminex Corporation recall?
Luminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results, dated Apr 16, 2025. Every Luminex Corporation recall is listed on this page, newest first.
Why are Luminex Corporation products recalled?
The most common reasons on record: Potential for a false-negative result. (6).
What should I do if I have a recalled Luminex Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Luminex Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.