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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-
Recalled August 13, 2025 · FDA recall Z-2274-2025 · Nuclein
Hazard
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) · FDA Class II
Units
710 units
Sold at
US distribution to: Florida, New York, Texas, and West Virginia
Description
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
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.
Manufacturer(s)
Nuclein LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →