Brand Name: DASH Rapid PCR Instrument recallZ-2861-2026 · Nuclein LLC · initiated Jun 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nuclein LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
FDA root cause category: Process control
What the company is doing
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/
Recall details
- Recall number
- Z-2861-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 25, 2025
- Posted by the FDA
- Aug 3, 2026
- Recalling firm
- Nuclein LLC
- Quantity
- 2
- Product code
- NSU
- FDA submissions
- K241652
- Distribution
- US Nationwide distribution in the state of Texas.
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DASH® Rapid PCR Instrument DASH-0002Nuclein, LLC · Instrumentation For Clinical Multiplex Test Systems2 recalls0 reports
Other devices under the same FDA submission
1 device cleared under K241652 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DASH® SARS-CoV-2 & Flu A/B Test Kit SG-0006Nuclein, LLC · Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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