DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu ...
FDA Recall #Z-2274-2025 — Class II — June 25, 2025
Product Description
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)
Recalling Firm
Nuclein LLC — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
710 units
Distribution
US distribution to: Florida, New York, Texas, and West Virginia
Code Information
Lot Code: Lot: BB02 UDI: (01)00850063063036(17)260220(10)BB02 Expiration Date: 20 Feb. 2026 Lot Code: Lot: BB03 UDI: (01)00850063063036(17)260220(10)BB03 Expiration Date: 20 Feb. 2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated