Nuclein LLC Recalls
3 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (3)
- Class II
October 22, 2025
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 In
Due to a software issue
- Class II
June 25, 2025
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provide
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
- Class II
June 25, 2025
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 Instru
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
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