DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & F

FDA device recall Z-2274-2025 · posted 2025-08-06 · Open, Classified

Recall details

Recalling firm

Nuclein LLC

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

QOF

Quantity affected

710 units

Distribution

US distribution to: Florida, New York, Texas, and West Virginia

Date initiated

2025-06-25

Date posted

2025-08-06

Location

Austin, TX

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