Nuclein recalls

Nuclein has 3 recalls on record with the FDA and USDA, the earliest in 2025 and the latest reported on 23 Sep 2026. 3 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls3since 2025

Last 12 months2reported

Class I00% of total

Ongoing3latest 23 Sep 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why nuclein is recalled

Device Malfunction267%
Potency & Assay133%

Product types

Test Kits & Diagnostics3100%

By year

2026267%
2025133%

Ongoing nuclein recalls

3 active

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
13 Aug 2025Device	CLASS II	Dash Sars-CoV-2 & Flu A/B Test recalled by Nuclein	Nuclein	Potency & Assay	4 states

All nuclein recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
13 Aug 2025Device	CLASS II	Dash Sars-CoV-2 & Flu A/B Test recalled by Nuclein	Nuclein	Potency & Assay	4 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.