FDA-Device2026-09-23Class IIPROCESSING DEFECT
Nuclein DASH Rapid PCR Instrument recalled for software issue affecting test results
What this means
Nuclein LLC is recalling specific units of the DASH Rapid PCR Instrument due to a software issue in versions 6.0.2, 6.0.4, 6.0.5, and 6.0.6. The affected instruments are used in clinical laboratories to detect infectious diseases through rapid PCR testing. The software problem may impact the accuracy or reliability of test results.
- Check if your DASH Instrument serial number matches the affected list provided by Nuclein LLC
- Contact Nuclein LLC or the FDA for guidance on software updates or device replacement
- Do not use an affected instrument until you receive instructions from the manufacturer
The agency's original wording
Hazard
Due to a software issue
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, , Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Vermont.
Affected count
182
Manufactured in
8305 Cross Park Dr, N/A, Austin, TX, United States
Products
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3164-2026Want us to check the next one for you?
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