Recall Z-3164-2026 · NSU Instrumentation For Clinical Multiplex Test Systems
Nuclein LLC
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 reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT)
| Date | Sep 14, 2026 (initiated Oct 22, 2025) |
| Status | Open, Classified |
| Reason | Due to a software issue |
| Root cause | Process control |
| Action | On 10/22/2025 a "Customer Advisory Notification" via email to customers informing them of a software update to deal with potential of aborted test runs due to Error Code 0x25000012 (Pressure wet filter error). Customer were informed that an over-the-air software update will automatically be available when the DASH Instrument is connected to the internet. For questions or assistance - Nuclein Customer Support at 1-888-992-DASH (3274) or customersupport@nuclein.com On 07/30/2026, an updated "URGENT: MEDICAL DEVICE CORRECTION" Letter was email to customers. The updated letter informed custome |
| Quantity | 182 |
| Distribution | US Nationwide distribution in the states of Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, , Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Vermont. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241652 | DASH® SARS-CoV-2 & Flu A/B Test Nuclein, LLC, Dec 20, 2024 |