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U.S. Department of Health and Human Services

Class 2 Device Recall DASH Rapid PCR Instrument

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 Class 2 Device Recall DASH Rapid PCR Instrumentsee related information
Date Initiated by FirmJune 25, 2025
Date PostedAugust 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2861-2026
Recall Event ID 99360
510(K)NumberK241652 
Product Classification Instrumentation for clinical multiplex test systems - Product Code NSU
ProductBrand 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 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
FEI Number 3014515702
Recalling Firm/
Manufacturer		 Nuclein LLC
8305 Cross Park Dr
Austin TX 78754-5154
For Additional Information ContactCustomer Support
+1-888-9923274
Manufacturer 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).
FDA Determined
Cause 2		Process control
ActionOn 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 in Commerce2
DistributionUS Nationwide distribution in the state of Texas.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NSU
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