DASH SARS-CoV-2 & Flu A/B Test recallZ-2274-2025 · Nuclein LLC · initiated Jun 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nuclein LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2274-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 25, 2025
- Posted by the FDA
- Aug 6, 2025
- Recalling firm
- Nuclein LLC
- Quantity
- 710 units
- Product code
- QOF
- FDA submissions
- K241652
- Distribution
- US distribution to: Florida, New York, Texas, and West Virginia
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DASH® SARS-CoV-2 & Flu A/B Test Kit SG-0006Nuclein, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K241652 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DASH® Rapid PCR Instrument DASH-0002Nuclein, LLC · Instrumentation For Clinical Multiplex Test Systems2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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