Nuclein Recalls
2 recalls on record · August 13, 2025 to August 12, 2026 · Medical Devices
Recalls by year
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026Medical DevicesFDA
Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software
Hazard: Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
August 13, 2025Medical DevicesFDA
Nuclein LLC recalls DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-
Hazard: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)