Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software…
Nuclein LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nuclein LLC · 8305 Cross Park Dr · Austin, TX · 78754-5154
Is this the product you have?
- Brand NameDASH
- Rapid PCR Instrument Product NameDASH Rapid
- PCR Instrument Model/Catalog NumberSG-0002
- Software Version6.0.2
- Product DescriptionThe 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
- ComponentNo
- Lot codes and dates
- Lot CodeSN: C01250010
- UDI(01)00850063063005(11)250218(21)C01250010
- SW6.0.2
- SNC02250006
- UDI(01)00850063063005(11)250225(21)C02250006
- SW6.0.2
- Amount recalled
- 2
Where it was sold
- Nationwide
- TX
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).
This product could cause temporary or reversible health problems — stop using it.
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