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Class IIOngoing

Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 So

Recall date · record updated Sep 23, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Nuclein LLC
Reason
Due to a software issue
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99356…

Products

  1. 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 Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.

    Codes/lots: Instrument Serial Numbers / UDI codes: C01250001 (01)00850063063005(11)250217(21)C01250001 C01250003 (01)00850063063005(11)250217(21)C01250003 C01250004 (01)00850063063005(11)250214(21)C01250004 C01250005 (01)00850063063005(11)250214(21)C01250005 C01250006 (01)00850063063005(11)250218(21)C01250006 C01250007 (01)00850063063005(11)250218(21)C01250007 C01250008 (01)00850063063005(11)250218(21)C01250008 C01250009 (01)00850063063005(11)250218(21)C01250009 C01250010 (01)00850063063005(11)250218(21)C01250010 C02250002 (01)00850063063005(11)250221(21)C02250002 C02250003 (01)00850063063005(11)250221(21Quantity: 182Recall no. Z-3164-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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