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.
Reported: August 13, 2025 Initiated: June 25, 2025 #Z-2274-2025
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.
Reason for Recall
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Details
- Recalling Firm
- Nuclein LLC
- Units Affected
- 710 units
- Distribution
- US distribution to: Florida, New York, Texas, and West Virginia
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nuclein LLC. Units affected: 710 units.
Why was this product recalled? ▼
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 13, 2025. Severity: Moderate. Recall number: Z-2274-2025.
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