Austin, TX, United States
Nuclein LLC recalls
3 recalls recorded since 2018, most recently on 22 October 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 October 2025
- Reason
- Due to a software issue
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3164-2026
- 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 Instr
Ongoing Class II Medical devices
- Recall started
- 25 June 2025
- Reason
- Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
- Distribution
- US distribution to: Florida, New York, Texas, and West Virginia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2274-2025
- 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 provided to users in quanti
Ongoing Class II Medical devices
- Recall started
- 25 June 2025
- Reason
- Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
- Distribution
- US Nationwide distribution in the state of Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2861-2026
- 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 automate
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.