FDA recall Z-2274-2025

Nuclein LLC · Class II · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-06-25
Report date
2025-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2274-2025