Z-2274-2025Class II

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

Name: Z-2274-2025 DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH...
Creator: Nuclein LLC
Published: 2025-06-25
License: https://open.fda.gov/license/

Nuclein, LLC / initiated 2025-06-25 / Open, Classified / root cause: manufacturing process

FDA source

Nuclein LLC began a recall of 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... on 2025-06-25. FDA classified it as Class II and gives the reason as "Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2274-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-25
Posted: 2025-08-06
Recalling firm: Nuclein, LLC
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.
Product code: QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Reason for recall: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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.
Quantity in commerce: 710 units
Distribution: US distribution to: Florida, New York, Texas, and West Virginia
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2274-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2274-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-06

Product code QOF

K241652Class IIDASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC / cleared 2024-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)