FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2274-2025
·
Reported August 13, 2025
Enforcement
- Recall Number
- Z-2274-2025
- Event ID
- 97228
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Nuclein LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- August 13, 2025
- Initiation Date
- June 25, 2025
- Classification Date
- August 6, 2025
- Address
- 8305 Cross Park Dr, N/A, Austin, TX, 78754-5154, United States
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
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Code Info
Lot Code: Lot: BB02 UDI: (01)00850063063036(17)260220(10)BB02 Expiration Date: 20 Feb. 2026 Lot Code: Lot: BB03 UDI: (01)00850063063036(17)260220(10)BB03 Expiration Date: 20 Feb. 2026
Distribution
US distribution to: Florida, New York, Texas, and West Virginia
Quantity
710 units