Brand
Nuclein LLC
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Nuclein LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-13FDA-DeviceClass IIDASH 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.
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
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