FDA-Device2025-08-13Class II
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.
Nuclein LLC
Hazard
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Sold states
US distribution to: Florida, New York, Texas, and West Virginia
Affected count
710 units
Manufactured in
8305 Cross Park Dr, N/A, Austin, TX, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2274-2025Don't want to check this manually?
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