Nuclein LLC recalls DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 &…

Recall date

June 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2274-2025

FDA classification

Class II

Brand / firm

Nuclein LLC

Sold / distributed

US distribution to: Florida, New York, Texas, and West Virginia

Why it was recalled

Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.