Z-2861-2026Class II

Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002...

Name: Z-2861-2026 Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002...
Creator: Nuclein LLC
Published: 2025-06-25
License: https://open.fda.gov/license/

Nuclein, LLC / initiated 2025-06-25 / Open, Classified / root cause: manufacturing process

FDA source

Nuclein LLC began a recall of 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... on 2025-06-25. FDA classified it as Class II and gives the reason as "Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2861-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-25
Posted: 2026-08-03
Recalling firm: Nuclein, LLC
Product: 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.
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 06/25/2025, a "MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that, Nuclein identified an incorrect software file on a small number of DASH instruments that creates a possibility for the affected instruments to make incorrect calls that indicate coinfection in the patient tested. On 07/16/2026, the firm emailed an updated "URGENT: MEDICAL DEVICE RECALL" Letter. -Customer were informed regarding updates to the reason for the recall and potential health risks. -Customer were instructed to: All affected DASH Instrument identified in Section 6 (below) have already been replaced. Please complete the Acknowledgement and Receipt Form below and either email the completed form to [email protected] or mail to the address provided at the bottom of the Acknowledgement and Receipt Form. For Questions - contact Nuclein at Phone: (888) 992-DASH on Monday through Friday, 8:30 AM to 5:30 PM, CST. Email: [email protected] Website: https://www.Nuclein.com/contact-us/
Quantity in commerce: 2
Distribution: US Nationwide distribution in the state of Texas.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2861-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2861-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03

Product code NSU

K241652Class IIDASH® SARS-CoV-2 & Flu A/B TestNuclein, LLC / cleared 2024-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)