Nuclein recalls

3 official recalls and safety alerts involving Nuclein since 2025-08, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Nuclein or the relevant agency.

1. 2026-09-23
2. US
   Drugs & medicalClass II

   Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2,…

   Due to a software issue

   FDA · DeviceNuclein LLCUS Nationwide distribution in the states of Alabama, Delaware, Florida,…Official notice →
3. 2026-08-12
4. US
   Drugs & medicalClass II

   Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2…

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

   FDA · DeviceNuclein LLCUS Nationwide distribution in the state of Texas.Official notice →
5. 2025-08-13
6. US
   Drugs & medicalClass II

   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-CoV-2 & Flu A/B Test is…

   Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)

   FDA · DeviceNuclein LLCUS distribution to: Florida, New York, Texas, and West VirginiaOfficial notice →