Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software
Summary
The FDA issued a Class II for Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument by Nuclein LLC. Reason: Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present)..
Details
Source
Device Recall
External ID
Z-2861-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 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.
Lot/Code Info: Lot Code: SN: C01250010; UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2 SN: C02250006; UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2
Quantity Affected: 2
Reason for Recall
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Distribution
US Nationwide distribution in the state of Texas.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-25
Company
Austin, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Nuclein LLC has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nuclein LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nuclein LLC have FDA actions?
Nuclein LLC has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2861-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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