FDAClass IIAugust 13, 2025

Dash Sars-cov-2 & Flu A/b Test recall

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…

Why was Dash Sars-cov-2 & Flu A/b Test recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Nuclein LLC
Quantity
710 units
Distribution
US distribution to: Florida, New York, Texas, and West Virginia
Recall date
August 13, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls