DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a high-risk pathogen diagnostic function where a software error could lead to incorrect diagnosis, though no injuries are reported.
Plain-English summary
Nuclein LLC has issued a recall for the DASH Rapid PCR Instrument (Model SG-0002, Software Version 6.0.2). This automated, fluorescence-based instrument is used to extract specimens and perform nucleic acid amplified tests (NAAT) for the qualitative detection of infectious diseases.
A software issue in the device may result in false co-infection results, such as a positive result for Flu A when SARS-CoV-2 is present. This may affect the accuracy of infectious disease diagnosis.
The affected units were distributed nationwide in the state of Texas. The recall involves specific units with serial numbers C01250010 and C02250006.
The recalled product
- 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…
- Manufacturer
- Nuclein LLC
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distribution
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