FDA · Class II · September 23, 2026

Nuclein recall: DASH Rapid PCR Instrument

Nuclein LLC is recalling DASH Rapid PCR Instrument – 182. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on October 22, 2025. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	DASH Rapid PCR Instrument
Brand	Nuclein
Company	Nuclein LLC
Type	Medical devices
Classification	Class II
Recall date	October 22, 2025
Published by FDA	September 23, 2026
Quantity	182
Recall ID	99356

As listed by FDA

Recalled products

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.
FDA recall number
Z-3164-2026
Codes, lots and dates
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(21)C02250003 C02250004 (01)00850063063005(11)250221(21)C02250004 C02250005 (01)00850063063005(11)250221(21)C02250005 C02250007 (01)00850063063005(11)250225(21)C02250007 C02250008 (01)00850063063005(11)250307(21)C02250008 C02250009 (01)00850063063005(11)250225(21)C02250009 C02250010 (01)00850063063005(11)250225(21)C02250010 C02250011 (01)00850063063005(11)250227(21)C02250011 C02250012 (01)00850063063005(11)250227(21)C02250012 C02250014 (01)00850063063005(11)250227(21)C02250014 C02250015 (01)00850063063005(11)250227(21)C02250015 C02250016 (01)00850063063005(11)250307(21)C02250016 C02250018 (01)00850063063005(11)250310(21)C02250018 C02250019 (01)00850063063005(11)250311(21)C02250019 C02250020 (01)00850063063005(11)250311(21)C02250020 C03250002 (01)00850063063005(11)250627(21)C03250002 C03250003 (01)00850063063005(11)250403(21)C03250003 C03250004 (01)00850063063005(11)250404(21)C03250004 C03250005 (01)00850063063005(11)250408(21)C03250005 C03250006 (01)00850063063005(11)250319(21)C03250006 C03250007 (01)00850063063005(11)250319(21)C03250007 C03250008 (01)00850063063005(11)250512(21)C03250008 C03250009 (01)00850063063005(11)250415(21)C03250009 C03250012 (01)00850063063005(11)250417(21)C03250012 C03250013 (01)00850063063005(11)250408(21)C03250013 C03250015 (01)00850063063005(11)250421(21)C03250015 C03250016 (01)00850063063005(11)250417(21)C03250016 C03250018 (01)00850063063005(11)250421(21)C03250018 C03250019 (01)00850063063005(11)250421(21)C03250019 C03250020 (01)00850063063005(11)250423(21)C03250020 C04250003 (01)00850063063005(11)250509(21)C04250003 C04250004 (01)00850063063005(11)250421(21)C04250004 C04250005 (01)00850063063005(11)250509(21)C04250005 C05250006 (01)00850063063005(11)250512(21)C05250006 C05250007 (01)00850063063005(11)250513(21)C05250007 C05250008 (01)00850063063005(11)250513(21)C05250008 C05250010 (01)00850063063005(11)250512(21)C05250010 C05250011 (01)00850063063005(11)250514(21)C05250011 C05250012 (01)00850063063005(11)250514(21)C05250012 C05250013 (01)00850063063005(11)250514(21)C05250013 C05250016 (01)00850063063005(11)250520(21)C05250016 C05250017 (01)00850063063005(11)250520(21)C05250017 C05250021 (01)00850063063005(11)250521(21)C05250021 C05250022 (01)00850063063005(11)250520(21)C05250022 C05250024 (01)00850063063005(11)250520(21)C05250024 C05250026 (01)00850063063005(11)250605(21)C05250026 C05250028 (01)00850063063005(11)250509(21)C04250028 C05250029 (01)00850063063005(11)250605(21)C05250029 C05250030 (01)00850063063005(11)250606(21)C05250030 C05250031 (01)00850063063005(11)250605(21)C05250031 C05250033 (01)00850063063005(11)250609(21)C05250033 C05250034 (01)00850063063005(11)250609(21)C05250034 C05250035 (01)00850063063005(11)250609(21)C05250035 C05250036 (01)00850063063005(11)250609(21)C05250036 C05250039 (01)00850063063005(11)250606(21)C05250039 C05250040 (01)00850063063005(11)250609(21)C05250040 C05250042 (01)00850063063005(11)250610(21)C05250042 C06250001 (01)00850063063005(11)250610(21)C06250001 C06250002 (01)00850063063005(11)250610(21)C06250002 C06250003 (01)00850063063005(11)250610(21)C06250003 C06250005 (01)00850063063005(11)250611(21)C06250005 C06250006 (01)00850063063005(11)250611(21)C06250006 C06250008 (01)00850063063005(11)250611(21)C06250008 C06250010 (01)00850063063005(11)250611(21)C06250010 C06250012 (01)00850063063005(11)250624(21)C06250012 C06250013 (01)00850063063005(11)250623(21)C06250013 C06250015 (01)00850063063005(11)250623(21)C06250015 C06250016 (01)00850063063005(11)250623(21)C06250016 C06250017 (01)00850063063005(11)250624(21)C06250017 C06250019 (01)00850063063005(11)250623(21)C06250019 C06250020 (01)00850063063005(11)250624(21)C06250020 C06250022 (01)00850063063005(11)250624(21)C06250022 C06250023 (01)00850063063005(11)250624(21)C06250023 C06250024 (01)00850063063005(11)250624(21)C06250024 C06250025 (01)00850063063005(11)250625(21)C06250025 C06250026 (01)00850063063005(11)250624(21)C06250026 C06250027 (01)00850063063005(11)250625(21)C06250027 C06250028 (01)00850063063005(11)250625(21)C06250028 C06250029 (01)00850063063005(11)250625(21)C06250029 C06250030 (01)00850063063005(11)250626(21)C06250030 C06250032 (01)00850063063005(11)250626(21)C06250032 C06250033 (01)00850063063005(11)250627(21)C06250033 C06250034 (01)00850063063005(11)250627(21)C06250034 C06250035 (01)00850063063005(11)250627(21)C06250035 C06250036 (01)00850063063005(11)250630(21)C06250036 C06250037 (01)00850063063005(11)250701(21)C06250037 C06250039 (01)00850063063005(11)250630(21)C06250039 C06250040 (01)00850063063005(11)250702(21)C06250040 C06250041 (01)00850063063005(11)250702(21)C06250041 C06250042 (01)00850063063005(11)250702(21)C06250042 C06250043 (01)00850063063005(11)250703(21)C06250043 C06250047 (01)00850063063005(11)250707(21)C06250047 C06250048 (01)00850063063005(11)250625(21)C06250048 C06250049 (01)00850063063005(11)250707(21)C05250049 C06250050 (01)00850063063005(11)250708(21)C06250050 C06250051 (01)00850063063005(11)250707(21)C06250051 C07250003 (01)00850063063005(11)250710(21)C07250003 C07250005 (01)00850063063005(11)250710(21)C07250005 C07250006 (01)00850063063005(11)250710(21)C07250006 C07250007 (01)00850063063005(11)250715(21)C07250007 C07250008 (01)00850063063005(11)250714(21)C07250008 C07250010 (01)00850063063005(11)250714(21)C07250010 C07250011 (01)00850063063005(11)250714(21)C07250011 C07250013 (01)00850063063005(11)250715(21)C07250013 C07250014 (01)00850063063005(11)250716(21)C07250014 C07250016 (01)00850063063005(11)250715(21)C07250016 C07250017 (01)00850063063005(11)250715(21)C07250017 C07250018 (01)00850063063005(11)250725(21)C07250018 C07250019 (01)00850063063005(11)250725(21)C07250019 C07250020 (01)00850063063005(11)250725(21)C07250020 C07250021 (01)00850063063005(11)250725(21)C07250021 C07250023 (01)00850063063005(11)250725(21)C07250023 C07250024 (01)00850063063005(11)250725(21)C07250024 C07250027 (01)00850063063005(11)250725(21)C07250027 C07250032 (01)00850063063005(11)250728(21)C07250032 C07250033 (01)00850063063005(11)250729(21)C07250033 C07250036 (01)00850063063005(11)250729(21)C07250036 C07250037 (01)00850063063005(11)250729(21)C07250037 C07250038 (01)00850063063005(11)250624(21)C07250038 C07250039 (01)00850063063005(11)250729(21)C07250039 C07250040 (01)00850063063005(11)250730(21)C07250040 C07250041 (01)00850063063005(11)250729(21)C07250041 C07250042 (01)00850063063005(11)250729(21)C07250042 C07250043 (01)00850063063005(11)250730(21)C07250043 C07250044 (01)00850063063005(11)250731(21)C07250044 C07250045 (01)00850063063005(11)250731(21)C07250045 C07250047 (01)00850063063005(11)250731(21)C07250047 C07250048 (01)00850063063005(11)250801(21)C07250048 C07250050 (01)00850063063005(11)250731(21)C07250050 C07250051 (01)00850063063005(11)250801(21)C07250051 C07250052 (01)00850063063005(11)250801(21)C07250052 C07250053 (01)00850063063005(11)250804(21)C07250053 C07250055 (01)00850063063005(11)250804(21)C07250055 C07250056 (01)00850063063005(11)250805(21)C07250056 C07250057 (01)00850063063005(11)250804(21)C07250057 C07250058 (01)00850063063005(11)250805(21)C07250058 C07250059 (01)00850063063005(11)250805(21)C07250059 C07250060 (01)00850063063005(11)250805(21)C07250060 C07250061 (01)00850063063005(11)250805(21)C07250061 C08250003 (01)00850063063005(11)250805(21)C08250003 C08250005 (01)00850063063005(11)250806(21)C08250005 C08250008 (01)00850063063005(11)250813(21)C08250008 C08250009 (01)00850063063005(11)250807(21)C08250009 C08250010 (01)00850063063005(11)250808(21)C08250010 C08250011 (01)00850063063005(11)250815(21)C08250011 C08250016 (01)00850063063005(11)250813(21)C08250016 C08250019 (01)00850063063005(11)250815(21)C08250019 C08250025 (01)00850063063005(11)250818(21)C08250025 C08250027 (01)00850063063005(11)250818(21)C08250027 C08250039 (01)00850063063005(11)250821(21)C08250039 C08250041 (01)00850063063005(11)250822(21)C08250041 C08250042 (01)00850063063005(11)250822(21)C08250042 C08250044 (01)00850063063005(11)250825(21)C08250044 C08250045 (01)00850063063005(11)250825(21)C08250045 C08250046 (01)00850063063005(11)250825(21)C08250046 C08250049 (01)00850063063005(11)250826(21)C08250049 C08250050 (01)00850063063005(11)250826(21)C08250050 C08250052 (01)00850063063005(11)250827(21)C08250052 C08250054 (01)00850063063005(11)250902(21)C08250054 C08250056 (01)00850063063005(11)250904(21)C08250056 C08250057 (01)00850063063005(11)250905(21)C08250057 C08250059 (01)00850063063005(11)250909(21)C08250059 C08250061 (01)00850063063005(11)250903(21)C08250061 C08250063 (01)00850063063005(11)250908(21)C08250063 C08250065 (01)00850063063005(11)250909(21)C08250065 C08250071 (01)00850063063005(11)250915(21)C08250071 C08250073 (01)00850063063005(11)250917(21)C08250073 C08250074 (01)00850063063005(11)250916(21)C08250074 C08250075 (01)00850063063005(11)250917(21)C08250075 C08250076 (01)00850063063005(11)250915(21)C08250076 C08250077 (01)00850063063005(11)250917(21)C08250077 C08250078 (01)00850063063005(11)250917(21)C08250078
Quantity
182
Classification
Class II

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99356
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Austin, TX, United States

Why it was recalled

The reason the FDA lists: “Due to a software issue”

Where it was sold

Nationwide. Distribution as the FDA records it: “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.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99356, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is Nuclein DASH Rapid PCR Instrument recalled?

Yes. Nuclein LLC recalled it on October 22, 2025; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Due to a software issue

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.