FDA Device recall Z-3164-2026
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,…
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of 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,… by Nuclein, citing due to a software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3164-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-22 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Nuclein |
| Distribution | US |
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 reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.
Reason
Due to a software issue
Identifiers
| code_info | Instrument Serial Numbers / UDI codes: C01250001 (01)00850063063005(11)250217(21)C01250001 C01250003 (01)00850063063005…Instrument Serial Numbers / UDI codes: C01250001 (01)00850063063005(11)250217(21)C01250001 C01250003 (01)00850063063005(11)250217(21)C01250003 C01250004 (01)00850063063005(11)250214(21)C01250004 C01250005 (01)00850063063005(11)250214(21)C01250005 C01250006 (01)00850063063005(11)250218(21)C01250006 C01250007 (01)00850063063005(11)250218(21)C01250007 C01250008 (01)00850063063005(11)250218(21)C01250008 C01250009 (01)00850063063005(11)250218(21)C01250009 C01250010 (01)00850063063005(11)250218(21)C01250010 C02250002 (01)00850063063005(11)250221(21)C02250002 C02250003 (01)00850063063005(11)250221(21)C02250003 C02250004 (01)00850063063005(11)250221(21)C02250004 C02250005 (01)00850063063005(11)250221(21)C02250005 C02250007 (01)00850063063005(11)250225(21)C02250007 C02250008 (01)00850063063005(11)250307(21)C02250008 C02250009 (01)00850063063005(11)250225(21)C02250009 C02250010 (01)00850063063005(11)250225(21)C02250010 C02250011 (01)00850063063005(11)250227(21)C02250011 C02250012 (01)00850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Nuclein
- Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product…
FDA Device · Class II · 2026-08-12 · Nuclein - DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test
FDA Device · Class II · 2025-08-13 · Nuclein
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3164-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.