Luminex Molecular Diagnostics recalls

Luminex Molecular Diagnostics has 4 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 16 Oct 2024. 4 are still ongoing.

Total recalls4since 2019

Last 12 months0reported

Class I00% of total

Ongoing4latest 16 Oct 2024

Recalls per month, last 24 months

click a bar for that month

2Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why luminex molecular diagnostics is recalled

Other Reasons375%
Potency & Assay125%

Product types

CPAP & Ventilators375%
Other Medical Devices125%

By year

2024250%
2019250%

Ongoing luminex molecular diagnostics recalls

4 active

Reported	Class	Recall	Company	Reason	Where
16 Oct 2024Device	CLASS II	NxTAG Respiratory Pathogen Panel recalled	Luminex Molecular Diagnostics	Other	Nationwide
16 Oct 2024Device	CLASS II	NxTAG Respiratory Pathogen Panel +Sars-CoV recalled	Luminex Molecular Diagnostics	Other	Nationwide
30 Oct 2019Device	CLASS II	xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP recalled	Luminex Molecular Diagnostics	Potency & Assay	4 states
19 Jun 2019Device	CLASS II	xTAG Gastrointestinal Pathogen Panel intended recalled	Luminex Molecular Diagnostics	Other	18 states

All luminex molecular diagnostics recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
16 Oct 2024Device	CLASS II	NxTAG Respiratory Pathogen Panel recalled	Luminex Molecular Diagnostics	Other	Nationwide
16 Oct 2024Device	CLASS II	NxTAG Respiratory Pathogen Panel +Sars-CoV recalled	Luminex Molecular Diagnostics	Other	Nationwide
30 Oct 2019Device	CLASS II	xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP recalled	Luminex Molecular Diagnostics	Potency & Assay	4 states
19 Jun 2019Device	CLASS II	xTAG Gastrointestinal Pathogen Panel intended recalled	Luminex Molecular Diagnostics	Other	18 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.