NeuMoDx Molecular recalls

NeuMoDx Molecular has 6 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 9 Aug 2023. 5 are still ongoing. The most frequent reason is potency & assay.

Total recalls6since 2021

Last 12 months0reported

Class I00% of total

Ongoing5latest 9 Aug 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '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 5 83%Class III 1 17%

Why neumodx molecular is recalled

Product types

By year

2023233%
2022350%
2021117%

Ongoing neumodx molecular recalls

5 active

Reported	Class	Recall	Company	Reason	Where
9 Aug 2023Device	CLASS II	NeuMoDx Cartridge-used for extraction, purification recalled	NeuMoDx Molecular	Other	Nationwide
12 Jul 2023Device	CLASS III	NeuMoDx Sars-CoV-2 Assay -Ivd intended recalled by NeuMoDx Molecular	NeuMoDx Molecular	Potency & Assay	Nationwide
15 Jun 2022Device	CLASS II	NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled	NeuMoDx Molecular	Lead & Heavy Metals	10 states
4 May 2022Device	CLASS II	NeuMoDx Cartridge-For in vitro diagnostic use recalled	NeuMoDx Molecular	Potency & Assay	Nationwide
16 Mar 2022Device	CLASS II	NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled	NeuMoDx Molecular	Potency & Assay	Nationwide

All neumodx molecular recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
9 Aug 2023Device	CLASS II	NeuMoDx Cartridge-used for extraction, purification recalled	NeuMoDx Molecular	Other	Nationwide
12 Jul 2023Device	CLASS III	NeuMoDx Sars-CoV-2 Assay -Ivd intended recalled by NeuMoDx Molecular	NeuMoDx Molecular	Potency & Assay	Nationwide
15 Jun 2022Device	CLASS II	NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled	NeuMoDx Molecular	Lead & Heavy Metals	10 states
4 May 2022Device	CLASS II	NeuMoDx Cartridge-For in vitro diagnostic use recalled	NeuMoDx Molecular	Potency & Assay	Nationwide
16 Mar 2022Device	CLASS II	NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled	NeuMoDx Molecular	Potency & Assay	Nationwide
7 Jul 2021Device	CLASS II	NeuMoDx Cartridge, For In Vitro Diagnostic Use on recalled	NeuMoDx Molecular	Potency & Assay	MI

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.