# FDA recall Z-2274-2025

> **Nuclein LLC** · Class II · device recall initiated 2025-06-25.

## 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)

## Distribution

US distribution to: Florida, New York, Texas, and West Virginia

## Key facts

- **Recall number:** Z-2274-2025
- **Recalling firm:** Nuclein LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-25
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2274-2025

## Citation

> AI Analytics. FDA recall Z-2274-2025. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-2274-2025. Source: US FDA. Licensed CC0.

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