Device recall
Z-3164-2026: Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument…
FDA device recall · Class II · Nuclein LLC
Key facts
| Recall number (Z-number) | Z-3164-2026 |
|---|---|
| Recall event | 99356 |
| Product | Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain… |
| Product code | NSU |
| 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
- 10–99 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