Device 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.
Z-2274-2025
Product summary
- Firm
- Nuclein LLC
- Event
- Event 97228
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 710 units
- Official record key
device-enforcement:Z-2274-2025
Official wording
Reason: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Code information: 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 pattern: US distribution to: Florida, New York, Texas, and West Virginia
Derived failure modes
-
Manufacturing or process control
manufacturing error