FEI 3014515702
Nuclein, Llc
8305 Cross Park Dr, 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 3014515702.
FDA inspections
2 on file
- Official Action Indicated (OAI)Jan 13, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jan 13, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Jan 13, 2026
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.198(c)Jan 13, 2026
Investigation of device failures
- 21 CFR 820.250(b)Jan 13, 2026
Sampling plans
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.