Device recall
Z-2274-2025: DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination…
FDA device recall · Class II · Nuclein LLC
Key facts
| Recall number (Z-number) | Z-2274-2025 |
|---|---|
| Recall event | 97228 |
| 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. |
| Product code | QOF |
| Recalling firm | Nuclein LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K241652 |
| FEI number | 3014515702 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database