FEI 3035381641
Nuclein, Llc
500 Center Ridge Dr Ste 400, Austin, TX, US
MDR events0All time
Recalls2All time
Registered products2
Establishment typeManufactureManufacture Medical Device
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
2 on file
- Open, ClassifiedAug 3, 2026
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
View FDA record ↗ - Open, ClassifiedAug 6, 2025
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
View FDA record ↗
Compliance history
Matched by FEI 3035381641.
FDA inspections
2 on file
- No Action Indicated (NAI)Jan 13, 2026
Compliance: Devices
- No Action Indicated (NAI)Jan 13, 2026
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.