Nuclein recalls

Nuclein has 2 recalls on record with the FDA and USDA, the earliest in 2025 and the latest reported on 12 Aug 2026. 2 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls2since 2025
Last 12 months1reported
Class I00% of total
Ongoing2latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why nuclein is recalled

Product types

By year

Ongoing nuclein recalls

2 active
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIDASH Rapid PCR Instrument recalled by NucleinNucleinDevice MalfunctionNationwide
DeviceCLASS IIDash Sars-CoV-2 & Flu A/B Test recalled by NucleinNucleinPotency & Assay5 states

All nuclein recalls, newest first

2 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIDASH Rapid PCR Instrument recalled by NucleinNucleinDevice MalfunctionNationwide
DeviceCLASS IIDash Sars-CoV-2 & Flu A/B Test recalled by NucleinNucleinPotency & Assay5 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.