Luminex recalls

Luminex has 39 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 11 Jun 2025. 27 are still ongoing.

Total recalls39since 2017

Last 12 months0reported

Class I00% of total

Ongoing27latest 11 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 1 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 38 97%Class III 1 3%

Why luminex is recalled

Product types

By year

202513%
202413%
202338%
2022923%
2021821%
2020513%
2019923%
201825%
201713%

Ongoing luminex recalls

27 active

Reported	Class	Recall	Company	Reason	Where
14 Aug 2024Device	CLASS II	Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test recalled	Luminex	Other Bacterial Contamination	Nationwide
13 Dec 2023Device	CLASS II	Verigene Bc-gp Utility Tray Carrier) recalled by Luminex	Luminex	Device Malfunction	Nationwide
5 Jul 2023Device	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex	Luminex	Other	Nationwide
5 Jul 2023Device	CLASS II	Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex	Luminex	Other Bacterial Contamination	Nationwide
2 Nov 2022Device	CLASS II	Aries Sars-CoV-2 Assay recalled by Luminex	Luminex	Potency & Assay	Nationwide
24 Aug 2022Device	CLASS II	Aries Sars-CoV-2 Assay recalled by Luminex	Luminex	Potency & Assay	Nationwide

All luminex recalls, newest first

39 total

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Device	CLASS II	Verigene Gram Negative Blood Culture (Bc-gn) Nucleic Acid Test recalled	Luminex	Other	Nationwide
14 Aug 2024Device	CLASS II	Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test recalled	Luminex	Other Bacterial Contamination	Nationwide
13 Dec 2023Device	CLASS II	Verigene Bc-gp Utility Tray Carrier) recalled by Luminex	Luminex	Device Malfunction	Nationwide
5 Jul 2023Device	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex	Luminex	Other	Nationwide
5 Jul 2023Device	CLASS II	Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex	Luminex	Other Bacterial Contamination	Nationwide
2 Nov 2022Device	CLASS II	Aries Sars-CoV-2 Assay recalled by Luminex	Luminex	Potency & Assay	Nationwide
24 Aug 2022Device	CLASS II	Aries Sars-CoV-2 Assay recalled by Luminex	Luminex	Potency & Assay	Nationwide
13 Jul 2022Device	CLASS II	Verigene CDF Nucleic Acid Test recalled by Luminex	Luminex	Other	Nationwide
13 Jul 2022Device	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test recalled by Luminex	Luminex	Other	Nationwide
25 May 2022Device	CLASS II	Verigene Nucleic Acid Test Kit-Bc-gn Extraction Tray recalled by Luminex	Luminex	Device Malfunction	IL
25 May 2022Device	CLASS II	Verigene Processor SP recalled by Luminex	Luminex	Potency & Assay	16 states
20 Apr 2022Device	CLASS II	Verigene Processor SP recalled by Luminex	Luminex	Other	CT, LA, TX
9 Feb 2022Device	CLASS II	Aries HSV 1&2 Assay recalled by Luminex	Luminex	Packaging Defects	Nationwide
26 Jan 2022Device	CLASS II	Aries HSV 1&2 Assay recalled by Luminex	Luminex	Packaging Defects	Nationwide
22 Sep 2021Device	CLASS II	Verigene EP Amplification Reagent Kit Test recalled by Luminex	Luminex	Other	Nationwide
14 Jul 2021Device	CLASS II	Verigene Gram-Positive Blood Culture Nucleic Acid Test (Bc-gp) recalled	Luminex	Other	Nationwide
14 Jul 2021Device	CLASS II	Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) recalled	Luminex	Other	Nationwide
14 Jul 2021Device	CLASS II	Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) recalled	Luminex	Other Bacterial Contamination	Nationwide
14 Jul 2021Device	CLASS II	Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex	Luminex	Other	Nationwide
14 Jul 2021Device	CLASS II	Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-gn) recalled	Luminex	Other	Nationwide
14 Jul 2021Device	CLASS II	Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) recalled	Luminex	Other	Nationwide
5 May 2021Device	CLASS II	Verigene Processor SP recalled by Luminex	Luminex	Salmonella	Nationwide
2 Dec 2020Device	CLASS II	Verigene Processor SP recalled by Luminex	Luminex	Potency & Assay	Nationwide
2 Dec 2020Device	CLASS II	Verigene Processor SP recalled by Luminex	Luminex	Potency & Assay	Nationwide
14 Oct 2020Device	CLASS II	Verigene Processor SP recalled by Luminex	Luminex	Device Malfunction	MO
19 Aug 2020Device	CLASS II	Verigene Processor SP with assay: Luminex recalled	Luminex	Device Malfunction	Nationwide
19 Aug 2020Device	CLASS II	Verigene Processor SP with assay Luminex recalled	Luminex	Device Malfunction	Nationwide
28 Aug 2019Device	CLASS II	Aries M1 System recalled by Luminex	Luminex	Device Malfunction	Nationwide
21 Aug 2019Device	CLASS II	Aries Extraction Kit recalled by Luminex	Luminex	Potency & Assay	34 states
21 Aug 2019Device	CLASS II	Aries Bordetella Assay recalled by Luminex	Luminex	Potency & Assay	34 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.