FDA Medical Device Recalls (openFDA)
Nuclein LLC: 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.
- Recall number
- Z-2861-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2025-06-25
- Posted
- 2026-08-03
- Terminated
- not on file
- 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).
- 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 customersupport@nuclein.com 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: customersupport@nuclein.com Website: https://www.Nuclein.com/contact-us/
- Quantity
- 2
- Distribution
- US Nationwide distribution in the state of Texas.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K241652"]
- PMA numbers
- not on file
- Product code
- NSU
- Firm FEI
- 3014515702
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28