FDA recall, , Moderate risk
Nuclein DASH Rapid PCR Instrument
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Summary by Recall Canary from the FDA notice
What happened
Nuclein LLC, based in Austin, Texas, is recalling the DASH Rapid PCR Instrument, model SG-0002, software version 6.0.2, due to a software issue that may result in false co-infection, such as a positive result for Flu A when SARS-CoV-2 is present. The instrument is an automated, fluorescence-based RT-PCR instrument used for qualitative detection of infectious diseases. The recall began on June 25, 2025, and was added to the FDA's Enforcement Report on August 3, 2026. Distribution was in Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
DASH Rapid PCR Instrument
- Model number
- SG-0002
- Lot code
- C01250010
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Texas.
- Company
- Nuclein LLCAustin, Texas
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99360
- Recall number
- Z-2861-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
