Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination Recalled by Nuclein LLC Due to Due to manufacturing error, assay test may result...

Date: June 25, 2025
Company: Nuclein LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nuclein LLC directly.

Affected Products

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.

Quantity: 710 units

Why Was This Recalled?

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

Where Was This Sold?

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

About Nuclein LLC

Nuclein LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report