Nuclein LLC recalls DASH Rapid PCR Instrument software version 6.0.2 due to potential false co-infection results. Affected units may show positive for flu A when SARS-CoV-2 is present. Consumers should contact Nuclein for details.
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Nuclein LLC is recalling DASH Rapid PCR Instrument software version 6.0.2 because it may produce false co-infection results, such as showing positive for flu A when SARS-CoV-2 is present. This could lead to incorrect disease diagnoses if the instrument is used for testing.
The software issue may cause the instrument to incorrectly detect flu A when SARS-CoV-2 is present. This could lead to false positive results for co-infections, potentially causing misdiagnosis of infectious diseases.
Users of the DASH Rapid PCR Instrument software version 6.0.2 are likely lab technicians or healthcare professionals. Those testing for infectious diseases using this instrument are most at risk of incorrect results.
Check for the model number SG-0002 with software version 6.0.2 on the instrument. The product was sold with specific serial numbers and lot codes as listed in the recall notice.
Reach out to Nuclein LLC for specific instructions on how to address the software issue.
The recall is for laboratory use only, as the DASH Rapid PCR Instrument is intended for professional diagnostic testing.
Check for model number SG-0002 with software version 6.0.2 on the instrument.
Contact Nuclein LLC for specific instructions on how to address the software issue.
We’ve drafted a message you can send Nuclein to request your refund or repair — edit it as you like.
Subject: Recall Z-2861-2026 — Nuclein Nuclein Hello, I own a Nuclein that is covered by recall Z-2861-2026 from Nuclein. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
