Nuclein LLC recalls DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-1…

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

On June 25, 2025, Nuclein, LLC issued a Urgent: Medical Device Recall notification to affected customers. On July 8, 2025 an updated notification was issued via E.Mail. a. Review your inventory of DASH SARS-CoV-2 & Flu A/B Tests to confirm the quantity of Lot BB02 or BB03 that you have remaining. b. Suspend the use and quarantine the affected lot of DASH SARS-CoV-2 & Flu A/B Tests; Nuclein will replace any unused affected product. c. Review all results of the product lots detailed in Section 6, below, to identify potentially erroneous diagnosis, except in those cases where alternative confirmation was obtained. d. Forward this information to all individuals and departments within your organization using the product information detailed in Section 6. If you are not the end user, forward this notice to the product end user. e. Complete the Acknowledgement and Receipt Form below and either email the completed form to customersupport@nuclein.com or mail to the address identified in the Acknowledgement and Receipt Form. f. Return the affected tests that you have remaining; Nuclein Customer Support will follow up with you on the details of returning or destroying the affected product.

• FDA enforcement recordOfficial FDA database entry for Z-2274-2025
• FDA 510(k) clearance · K241652The device's official FDA premarket clearance record
• FDA device classification · QOFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3981The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Nuclein LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.