Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/C…

Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 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.

On 06/25/2025, a "MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that, Nuclein identified an incorrect software file on a small number of DASH instruments that creates a possibility for the affected instruments to make incorrect calls that indicate coinfection in the patient tested. On 07/16/2026, the firm emailed an updated "URGENT: MEDICAL DEVICE RECALL" Letter. -Customer were informed regarding updates to the reason for the recall and potential health risks. -Customer were instructed to: All affected DASH Instrument identified in Section 6 (below) have already been replaced. Please complete the Acknowledgement and Receipt Form below and either email the completed form to customersupport@nuclein.com or mail to the address provided at the bottom of the Acknowledgement and Receipt Form. For Questions - contact Nuclein at Phone: (888) 992-DASH on Monday through Friday, 8:30 AM to 5:30 PM, CST. Email: customersupport@nuclein.com Website: https://www.Nuclein.com/contact-us/

• FDA enforcement recordOfficial FDA database entry for Z-2861-2026
• FDA 510(k) clearance · K241652The device's official FDA premarket clearance record
• FDA device classification · NSUOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Nuclein LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.