FDAHealthJune 25, 2025
Nuclein LLC — 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 tes
⚠️ Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- June 25, 2025
US distribution to: Florida, New York, Texas, and West Virginia
What's affected?
- 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.
- Brand
- Nuclein LLC
- Lot code
- Lot:
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 710 units.
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