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RecallWatchMedical Device Safety
Class IIOngoingZ-3164-2026

Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/C…

Nuclein LLCAustin, TX, United StatesReported Sep 23, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

Due to a software issue

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI codes
    182 affected lots
    C01250001C01250003C01250004C01250005C01250006C01250007C01250008C01250009
    +174 moreC01250010C02250002C02250003C02250004C02250005C02250007C02250008C02250009C02250010C02250011C02250012C02250014C02250015C02250016C02250018C02250019C02250020C03250002C03250003C03250004C03250005C03250006C03250007C03250008C03250009C03250012C03250013C03250015C03250016C03250018C03250019C03250020C04250003C04250004C04250005C05250006C05250007C05250008C05250010C05250011C05250012C05250013C05250016C05250017C05250021C05250022C05250024C05250026C05250028C05250029C05250030C05250031C05250033C05250034C05250035C05250036C05250039C05250040C05250042C06250001C06250002C06250003C06250005C06250006C06250008C06250010C06250012C06250013C06250015C06250016C06250017C06250019C06250020C06250022C06250023C06250024C06250025C06250026C06250027C06250028C06250029C06250030C06250032C06250033C06250034C06250035C06250036C06250037C06250039C06250040C06250041C06250042C06250043C06250047C06250048C06250049C06250050C06250051C07250003C07250005C07250006C07250007C07250008C07250010C07250011C07250013C07250014C07250016C07250017C07250018C07250019C07250020C07250021C07250023C07250024C07250027C07250032C07250033C07250036C07250037C07250038C07250039C07250040C07250041C07250042C07250043C07250044C07250045C07250047C07250048C07250050C07250051C07250052C07250053C07250055C07250056C07250057C07250058C07250059C07250060C07250061C08250003C08250005C08250008C08250009C08250010C08250011C08250016C08250019C08250025C08250027C08250039C08250041C08250042C08250044C08250045C08250046C08250049C08250050C08250052C08250054C08250056C08250057C08250059C08250061C08250063C08250065C08250071C08250073C08250074C08250075C08250076C08250077C08250078

What the firm is doing

On 10/22/2025 a "Customer Advisory Notification" via email to customers informing them of a software update to deal with potential of aborted test runs due to Error Code 0x25000012 (Pressure wet filter error). Customer were informed that an over-the-air software update will automatically be available when the DASH Instrument is connected to the internet. For questions or assistance - Nuclein Customer Support at 1-888-992-DASH (3274) or customersupport@nuclein.com On 07/30/2026, an updated "URGENT: MEDICAL DEVICE CORRECTION" Letter was email to customers. The updated letter informed customer of the potential issues associated with the software issue that was not addressed in the initial letter sent on 10/22/2025.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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