Class II — Nuclein LLC
| Recalling firm | Nuclein, LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) |
| 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. |
| Quantity | 710 units |
| Distribution | US distribution to: Florida, New York, Texas, and West Virginia |
| Initiated | 2025-06-25 |
| Classified | 2025-08-06 |
| Recall number | Z-2274-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nuclein LLC (Z-2274-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97228/
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