DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006… — Class II medical device recall Z-2274-2025
Ongoing recall by Nuclein LLC, reported 2025-08-13, distributed in FL, NY, TX, WV. Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false
| Recall number | Z-2274-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nuclein LLC, Austin, TX, United States |
| Recall initiated | 2025-06-25 |
| Classified | 2025-08-06 |
| Reported by FDA | 2025-08-13 |
| Distributed | FL, NY, TX, WV |
| Quantity | 710 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00850063063036 |
| Lot numbers | BB02, BB03 |
| Model numbers | SG-0006 |
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.
Reason for recall
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2274-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.