DASH SARS-CoV-2 & Flu Test (Nuclein) – Diagnostic Accuracy (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
Brand
Nuclein LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Nuclein LLC is recalling DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. due to Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, NY, TX, VA, WV
Page updated: Jan 10, 2026