Nuclein LLC recalls DASH Rapid PCR Instrument
Nuclein LLC recalled 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… beginning October 22, 2025, in a medical device recall whose distribution included Ohio. The stated reason: Due to a software issue FDA graded it Class II — use may cause temporary or medically reversible health consequences. Quantity affected: 182. The recall is listed as ongoing.
Writing the report from the record…
The source filing
| Recall number | Z-3164-2026 |
|---|---|
| Recalls in this action | 1 |
| Recalling firm | Nuclein LLC |
| 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 in |
| Reason for recall | Due to a software issue |
| Classification | Class II — use may cause temporary or medically reversible health consequences |
| Recall type | medical device |
| Quantity | 182 |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm initiated |
| Initiated | 20251022 |
| Reported | 20260923 |
| 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. |
| Firm location | Austin, TX, United States |
Published by U.S. Food and Drug Administration (openFDA). This is the agency's public filing as The Lantern received it, shown with its fields named in plain English.