Facility

Nuclein, LLC

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3035381641
Establishment type	Manufacture Medical Device
Location	500 Center Ridge Dr Ste 400 Austin, TX, US 78753
Registration status	Active · expires 2026
Parent company	Nuclein, LLC (owner-operator 10092415)
Brand names	DASH® SARS-CoV-2 & Flu A B Positive Control; DASH® Rapid PCR Instrument; DASH® Negative Control; DASH® SARS-CoV-2 & Flu A/B Test

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (2)

Instrumentation For Clinical Multiplex Test Systems
Product code NSU (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.2570
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Product code QOF (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3981

Recalls & enforcement

Class IIOngoing2025-10-22
Due to a software issue
Class IIOngoing2025-06-25
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Class IIOngoing2025-06-25
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)

FDA inspections (1)

NAI2026-01-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Nuclein, LLC (FEI 3035381641) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3035381641-nuclein-llc/

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