Nuclein LLC: Device Recall
Recall #Z-2274-2025 · 06/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2274-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Nuclein LLC
- Status
- Ongoing
- Date Initiated
- 06/25/2025
- Location
- Austin, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 710 units
Reason for Recall
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
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.
Distribution Pattern
US distribution to: Florida, New York, Texas, and West Virginia
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.